PSUR Synchronisation List - December 2011
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PSUR Synchronisation List - December 2011

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A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

acebutolol + mefruside 19820329 201203<br />

Next DLP Firm's Name Comments<br />

acebutolol + nifedipine Tredalat 19850416 201204 Bayer Schering<br />

aceclidine<br />

19660406 201304<br />

acediasulfone 201208<br />

acedobene + dimepranol + inosine<br />

Isoprinosine/Delimmun 19780808 201208 Sanofi Aventis<br />

acemetacin <strong>2011</strong>10<br />

acenocoumarol 19550706 201407 Novartis<br />

acetazolamide 19530727 201307<br />

acetylcholine 19650609 201406 Novartis<br />

acetylcysteine 19630914 201209 BMS<br />

acetylcysteine + tuaminoheptane<br />

19710301 201209 Zambon<br />

acetyldigoxin 201310<br />

acetyldigoxin combinations 201310<br />

acetylsalicylic acid 19570105 201302 Bayer Schering<br />

acetylsalicylic acid combinations<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong><br />

In orange font: all the important changes since last publication in September <strong>2011</strong><br />

201302<br />

acexamic acid 19680412 201404 Sanofi Aventis<br />

acriflavinium chloride + menthol +<br />

resorcinol<br />

<strong>2011</strong>11<br />

acrivastine 201212<br />

adapalene + benzoyl peroxide Epiduo / Tactuo / Tactuoben 20070930 201309 Galderma<br />

Deletion of the Marketing Authorisation<br />

of the innovator MSD in EEA.<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 1/61

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A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

ademetionine 19930428 201304 Abbott<br />

adrafinil 19810710 201201 Cephalon<br />

Next DLP Firm's Name Comments<br />

adrenaline 19520515 201305 Sanofi Aventis<br />

aescin + diethylamine salicylate 201204 Bayer Schering<br />

ajmaline 19900222 201308 Servier<br />

alclometasone 19870603 201210 Merck & Co.<br />

alendronate + colecalciferol<br />

(Vitamin D)<br />

201401<br />

alfacalcidol 19780131 201202<br />

alfentanil 201209 J&J<br />

alfoscerate olamine 19930301 201306 Bracco<br />

algeldrate 201301<br />

alibendole 19701019 201310 Sanofi Aventis<br />

alimemazine 19560605 201212 Sanofi Aventis<br />

allantoin 201311<br />

allantoin + combinations 201311<br />

allopurinol 19660101 201212 GSK<br />

allopurinol + benzbromarone 201212<br />

almitrine 19821210 201304 Servier<br />

alpha amylase 19670606 201306 Sanofi Aventis<br />

alpha amylase + bacitracine Maxilase Bacitracine 201306<br />

alpha chymotrypsin 19590703 201207 Sanofi Aventis<br />

alpha dihydroergocryptine 19890601 201407<br />

altizide 201211<br />

altizide + spironolactone 201211<br />

altretamine 19790122 201401 Sanofi Aventis<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 2/61

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A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

aluminium +/or calcium +/or<br />

magnesium antacids 201301<br />

aluminium acetotartrate +<br />

methylcitrine<br />

Cataplasme<br />

à l'acetotartrate d'alumine / Gel<br />

d'alumine<br />

Next DLP Firm's Name Comments<br />

19550302 201203 Sanofi Aventis<br />

alverine 19500210 201302 Sanofi Aventis<br />

alverine + simeticone Meteospasmyl 19900605 201302 Mayoly Spindler<br />

amantadine 19651214 201212 Novartis<br />

ambazone 201208<br />

ambenonium 19561214 <strong>2011</strong>12 Sanofi Aventis<br />

ambroxol + clenbuterol Spasmo-mucosolvan 19840627 201309 Boehringer Ingelheim<br />

ambroxol + doxycycline <strong>2011</strong>09<br />

amcinonide + neomycin 19840201 <strong>2011</strong>12<br />

amidotrizoate 201311<br />

amilomer 19861029 <strong>2011</strong>12<br />

amiloride<br />

19690425 201404<br />

amiloride + chlortalidone 19690425 201404<br />

amiloride + hydrochlorthiazide 19690425 201404 MSD<br />

amiloride + hydrochlorthiazide +<br />

methyldopa<br />

19690425 201404<br />

amiloride + hydrochlorthiazide +<br />

timolol<br />

19690425 201404<br />

aminoglutethimide 19801029 <strong>2011</strong>10 Novartis<br />

aminohippurate 19630224 201302<br />

aminophylline 19630224 201312 Recordati S.p.A.<br />

All antacids have the same DLP<br />

excluding combinations with dimeticone<br />

Deletion of the Marketing Authorisation<br />

of the innovator MSD in EEA.<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 3/61

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86<br />

87<br />

88<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

amiodarone 19661220 <strong>2011</strong>12 Sanofi Aventis<br />

amitriptyline 201201 MSD<br />

amitriptyline + amitriptylinoxide 19610731 201307 Sanofi Aventis<br />

amitriptyline + perphenazine 19610731 201307<br />

amitriptylinoxide 201307<br />

amlodipine + benazepril Lotrel 19950303 201203 Novartis<br />

ammonia solutions After Bite 19840919 201204 Tender Limited<br />

ammonium chloride +<br />

combinations<br />

201211<br />

amoxapine 19730601 201205<br />

amoxicillin 19720307 201203 GSK<br />

amoxicillin + clavulanate Augmentin 19720307 201203 GSK<br />

amoxicillin + metronidazole 19720307 201203<br />

amphetamine 201301<br />

amphetamine +<br />

dextroamphetamine<br />

201301<br />

amphotericin B 19580319 201203 BMS<br />

amphotericin B + tetracycline<br />

19580319 201203 BMS<br />

ampicillin 19620301 201303 GSK<br />

ampicillin + cloxacillin 201303<br />

ampicillin + sulbactam Unasyn IM/IV 19870224 201202 Pfizer<br />

amrinone 19840102 201201 Sanofi Aventis<br />

amyl nitrite 19730131 <strong>2011</strong>12<br />

amyleine + chlorhexidine 201308<br />

<strong>PSUR</strong> with DLP Mar 2012 will be the last<br />

<strong>PSUR</strong> BMS will submit for this product<br />

combination<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 4/61

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106<br />

107<br />

108<br />

A B C D E F<br />

Active substance name (INN)<br />

amylmetacresol + dichlorobenzyl<br />

alcohol<br />

amylmetacresol + dichlorobenzyl<br />

alcohol + levomenthol<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

Strepsils Original 19580901 201407 Reckitt Benckiser<br />

Strepsils 19580901 201407 Reckitt Benckiser<br />

amylmetacresol + dichlorobenzyl<br />

alcohol + lidocaine Strepsils Plus 19580901 201407 Reckitt Benckiser<br />

amylsalicylate + methylnicotinate+<br />

levomenthol Sedartryl 19600531 201305<br />

antazoline <strong>2011</strong>10<br />

antazoline + naphazoline Antistin-Privin 19610601 <strong>2011</strong>10 Novartis<br />

antazoline + tetryzoline Spersallerg 19721003 <strong>2011</strong>10 Novartis<br />

antazoline + xylometazoline Otrivin/Otrivine-antistin 19660101 <strong>2011</strong>10 Novartis<br />

antilymphocyte immunoglobulins<br />

19830209 201211 Pfizer<br />

apraclonidine 19670816 201405 Alcon<br />

aquatain 19960825 201408<br />

articaine 19750429 201204 Sanofi Aventis<br />

articaine + adrenaline Ultracain DS /<br />

Suprarenina<br />

19750429 201204 Sanofi Aventis<br />

astemizole 201407<br />

atenolol 19760219 201302 AstraZeneca<br />

atenolol + indapamide 201302<br />

atropine 19450831 201408 Laboratoire Théa<br />

atropine + diphenoxylate Lomotil 19600929 201309<br />

attapulgite 19621114 201311 IPSEN<br />

attapulgite + aluminium hydroxide<br />

and magnesium carbonate codried<br />

gel<br />

Gastropulgite 19670221 201402 IPSEN<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 5/61

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

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109 auranofin 201211<br />

110 aureomycine 19920818 201303<br />

111 aurothiomalate 19470729 201307 Sanofi Aventis<br />

112 azathioprine 19651213 <strong>2011</strong>12 GSK<br />

113 azulenolum 201211<br />

114 bacampicillin 201202<br />

115 bacillus Cereus 19530101 201312 Sanofi Aventis<br />

116 bacitracin 19620402 <strong>2011</strong>12<br />

117 bacitracin + chlorhexidine <strong>2011</strong>12<br />

118<br />

bacitracin + colistimethate sodium<br />

+ hydrocortisone acetate<br />

19620402 <strong>2011</strong>12<br />

119 bacitracin + neomycin <strong>2011</strong>12<br />

120<br />

bacitracin + neomycin +<br />

prednisolone<br />

<strong>2011</strong>12<br />

121 baclofen (intrathecal) 19630116 201312 Novartis<br />

122 baclofen (oral) 19700917 <strong>2011</strong>09 Novartis<br />

123 bacterial Lysate IRS19, Imudon 19880119 201401<br />

124 bamifyline 19780206 201401 UCB<br />

125 bamipine <strong>2011</strong>10<br />

126 barbexaclone 19661004 201310<br />

barium sulphate + combninations Micropaque, Micropaque<br />

Colon, Micropaque Scanner, 19730801 201304 Guerbet<br />

127<br />

Microstat<br />

128<br />

beclomethasone 19661231 <strong>2011</strong>12 GSK<br />

129<br />

belladona alkaloids, ergotamine,<br />

phenobarbital<br />

19340115 201401<br />

130<br />

belladonna extract + hyoscyamine<br />

+ papaverine<br />

Antispasmina Colica 19500221 201312 Recordati S.p.A.<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 6/61

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A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

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131<br />

bemetezide + triamterene 19810311 201206 UCB<br />

132 bendazac 19681109 201210 Acraf<br />

133 bendroflumethiazide 19600228 201305 LEO Pharma<br />

134<br />

bendroflumethiazide +<br />

spironolactone<br />

201211<br />

135<br />

benorilate<br />

19750400 201403<br />

136<br />

benserazide + levodopa Madopar 19730627 201206 Roche<br />

137<br />

benzalkonium chloride (incl<br />

ocular)<br />

<strong>2011</strong>10<br />

138<br />

benzalkonium chloride + benzyl<br />

alcohol + chlorhexedine<br />

<strong>2011</strong>10<br />

139<br />

benzalkonium chloride + cetrimide<br />

benzalkonium chloride +<br />

<strong>2011</strong>10<br />

chloroxylenol + disodium edetate Dettol Clear 19910131 <strong>2011</strong>10 Reckitt Benckiser<br />

benzalkonium chloride +<br />

dequalinium chloride<br />

benzalkonium chloride +<br />

dimethicone<br />

benzalkonium chloride +<br />

dimethicone + hydrocortisone +<br />

nystatin<br />

benzalkonium chloride +<br />

hexylresorcinol<br />

benzalkonium chloride + lidocaine Dettol Antiseptic Pain Relief<br />

Spray<br />

benzalkonium chloride +<br />

oxymetalozine<br />

<strong>2011</strong>10<br />

Timodine Intertrigo Relief 19961003 <strong>2011</strong>10 Reckitt Benckiser<br />

19720531 201208<br />

<strong>2011</strong>10<br />

19961027 201203 Reckitt Benckiser<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 7/61<br />

201308

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166<br />

A B C D E F<br />

Active substance name (INN)<br />

benzalkonium chloride + tolnaftate<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

Mycil Ointment 19910226 <strong>2011</strong>10 Reckitt Benckiser<br />

benzatropine 201303<br />

benzbromarone 19701015 <strong>2011</strong>10 Pro Strakan<br />

benzethonium chloride<br />

201305<br />

benzocaine 201207<br />

benzocaine + cetylpyridium<br />

chloride<br />

Dolo-Dobendan 19960101 201207 Reckitt Benckiser<br />

benzocaine + chlorhexidine 201207<br />

benzocaine + chloroxylenol Rinstead AdultGel 201207 Merck & Co.<br />

benzocaine + dequalinium<br />

hydrochloride<br />

benzocaine + triclosan<br />

Dequacaine 19910409 201207 Reckitt Benckiser<br />

Solarcaïne 201207 Merck & Co.<br />

benzocaine + tyrothricin 201406<br />

benzododecinium bromide<br />

bendroflumethiazide + propanolol<br />

+ hydralazine 201203 UCB Typo corrected in the combination name<br />

Benzoxonium chloride<br />

201306<br />

19690201 <strong>2011</strong>10 Novartis<br />

benzoyl peroxide 19500301 201404 Reckitt Benckiser<br />

benztropine mesylate<br />

19590713 201212 Lundbeck<br />

benzydamine 19640710 201210 Acraf<br />

benzydamine + benzalkonium Mediplus 201210 Acraf<br />

benzydamine + cetylpyridine Tantum Orosan 201210 Acraf<br />

benzylbenzoate 201302<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 8/61

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190<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

benzylnicotinate 201204<br />

benzylnicotinate + hydroxyethyl<br />

salicylate<br />

Next DLP Firm's Name Comments<br />

201204<br />

benzylpenicillin 19520627 201406<br />

benzylpenicillin combinations 201408<br />

beta-carotene 201304<br />

betaine citrate 19760719 201207 BMS<br />

betamethasone 19610925 201209 GSK<br />

betamethasone combinations Many combinations and brand<br />

names<br />

201209<br />

betamethyldigoxin 201310<br />

bezafibrate 19780721 201207 Actavis<br />

biclotymol 20030611 201206 Sanofi Aventis<br />

bifonazole 19821201 201212 Bayer Schering<br />

bile acids and salts 201308<br />

biperiden 19550816 201308 Abbott<br />

bisacodyl<br />

19540601 201304 Boehringer Ingelheim<br />

bisacodyl combinations Prepacol 19830331 201304 Guerbet<br />

bismuth salts and combinations 201206<br />

bisulepin 201309<br />

bleomycin 19700318 201403 Baxter / Sanofi Aventis<br />

bopindolol 19841130 201211 Novartis<br />

borax/boric acide (eye bath) 201308<br />

bretylium 19910129 201204<br />

brivudine 20000706 201406 Menari<br />

bromelains 19680330 201312 Sanofi Aventis<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 9/61

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201<br />

202<br />

203<br />

204<br />

205<br />

206<br />

207<br />

208<br />

209<br />

210<br />

A B C D E F<br />

Active substance name (INN)<br />

bromhexine<br />

bromhexine + eucalypti etheroeum<br />

+ ainisi aetheroleum + foeniculi<br />

etheroleum + levomentholum +<br />

menthae piperitae eleum + origani<br />

etheroleum<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

19630701 201401 Boehringer Ingelheim<br />

Bronchosan 201401 Slovakofarma<br />

bromocryptine 19751015 201210<br />

brompheniramine<br />

19590808 201408<br />

buclizine 19530701 201406 Pierre Fabre<br />

bufexamac<br />

19720801 201207 Pfizer<br />

bufexamac + lidocaine <strong>2011</strong>12<br />

buformin 201310<br />

bumetanide 19720930 201210 LEO Pharma<br />

bupivacaine 19660427 201404 AstraZeneca<br />

bupivacaine + adrenaline Marcaine - Adrenaline 19660427 201404 AstraZeneca<br />

busulphan 19540125 201201 GSK<br />

butamirate 201311 Novartis<br />

butamirate + guaifenesin 201205<br />

butenafine<br />

20010710 201205<br />

butorphanol 19770824 201408<br />

cafedrine 201311<br />

caffeine 19690414 201302 Merck Serono<br />

caffeine + diphenhydramine 201203<br />

caffeine + ergotamine Cafergot 201211 Novartis<br />

The innovator product from Pfizer is<br />

approved in France only<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 10/61

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212<br />

213<br />

214<br />

215<br />

216<br />

217<br />

218<br />

219<br />

220<br />

221<br />

222<br />

223<br />

224<br />

225<br />

226<br />

227<br />

228<br />

229<br />

230<br />

231<br />

232<br />

233<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

caffeine + isometheptene+<br />

metamizole<br />

201204<br />

caffeine + phenazone <strong>2011</strong>09<br />

Next DLP Firm's Name Comments<br />

calcipotriol 19901130 201401 LEO Pharma<br />

calcium +/or aluminium +/or<br />

magnesium antacids<br />

201301<br />

calcium levofolinate 19910309 201303 Pfizer<br />

calcium salts not used in antacids<br />

or vitamin preparations<br />

201307<br />

calcium + dexamethasone +<br />

lidocaine<br />

201203<br />

calcium + lidocaine 201203<br />

camphor 201205<br />

camphor + combinations Vicks 19050222 201205<br />

canrenoate 19670906 <strong>2011</strong>09 Pfizer<br />

capreomycin 19680119 201401 Eli Lilly<br />

capsaicin 19920820 <strong>2011</strong>09 Cephalon<br />

carbachol 19651110 201301 Alcon<br />

carbaethopendecinium 201403<br />

carbamazepine 19611212 201212 Novartis<br />

carbasalate calcium<br />

19810716 201307<br />

carbasalate calcium +<br />

metoclopramide<br />

19810716 201307<br />

carbazochrome 19510319 201203 Sanofi Aventis<br />

carbenicillin 19700806 201408<br />

carbidopa + levodopa 19730813 201210 MSD<br />

carbimazole 201206<br />

carbocisteine 19630914 201209 BMS<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 11/61

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240<br />

241<br />

242<br />

243<br />

244<br />

245<br />

246<br />

247<br />

248<br />

249<br />

250<br />

251<br />

252<br />

253<br />

254<br />

255<br />

256<br />

257<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

carbocisteine + prenoxidiazine Broncofluid 201209 Recofarma s.r.l.<br />

carbolevure 19690331 201302 Pierre Fabre<br />

carbomer (artificial tears) Viscotears 19850101 201401 Novartis<br />

carboxymethylcellulose (eye<br />

preparation)<br />

carbutamide<br />

19901001 201207 Allergan<br />

19971218<br />

carisoprodol 201405<br />

201304 Servier<br />

carmustine 19740423 201204 BMS<br />

carnitine 19690901 201206 Sigma-Tau<br />

catalase + neomycin Pulvo Neomycin <strong>2011</strong>12 Abbott<br />

cefaclor 19760819 201408 Eli Lilly<br />

cefadroxil 19760712 201207 BMS<br />

cefalotin sodium 201201<br />

cefamandole 19770829 201208 Eli Lilly<br />

cefatrizine 19790827 201308 BMS<br />

cefazolin 19721129 <strong>2011</strong>11 Pfizer<br />

cefixime 19870630 201206 Astellas<br />

cefodizime<br />

19900330 201203 Sanofi Aventis<br />

cefonicid 201406<br />

ceforanide 19860701 201206<br />

cefotiam 19851026 <strong>2011</strong>10 Sanofi Aventis<br />

cefoxitin 19770316 201303<br />

cefpiramide 201407<br />

cefpirome 19920904 201209 Sanofi Aventis<br />

cefpodoxim 19900802 201208 Sanofi Aventis<br />

Innovator product withdrawn from the<br />

market in AT (former P-RMS)<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 12/61

2<br />

258<br />

259<br />

260<br />

261<br />

262<br />

263<br />

264<br />

265<br />

266<br />

267<br />

268<br />

269<br />

270<br />

271<br />

272<br />

273<br />

274<br />

275<br />

276<br />

277<br />

278<br />

279<br />

280<br />

A B C D E F<br />

Active substance name (INN)<br />

cefradine<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

19711123 <strong>2011</strong>11 BMS<br />

cefsulodin 19801030 <strong>2011</strong>10 Takeda<br />

ceftizoxime 19811207 201210 Astellas<br />

celiprolol 19830117 201201 Sanofi Aventis<br />

celsior 20040325 201203 Genzyme<br />

cephalexin 19670315 201403 Eli Lilly<br />

cephapirin<br />

19721215 201312 BMS<br />

cernitin 201311<br />

certoparin 201407<br />

cetalkonium + choline salicylate Bonjela Original 19950424 201303 Reckitt Benckiser<br />

cetalkonium + lidocaine Bonjela Teething Gel 19950424 201203 Reckitt Benckiser<br />

cetrimide + chlorhexidine 201308<br />

cetylpyridinium 19390323 201208 Sanofi Aventis<br />

cetylpyridinium + ascorbic acid 201208<br />

cetylpyridinium + dequalinium<br />

chloride<br />

201208<br />

cetylpyridinium + lidocaine 201208<br />

cetylpyridinium + lysozyme 201208<br />

cetylpyridinium + menthol Rinsted Pastilles 19880404 201208 Merck & Co.<br />

charcoal activated 19490406 201208 Merck Serono<br />

chenodesoxicholic acid 19750101 201405<br />

chlorambucil 19560914 201309 GSK<br />

chloramphenicol 19490625 201306 Pfizer<br />

chloramphenicol + aminoacids +<br />

Vitamin A<br />

201303<br />

<strong>PSUR</strong> with DLP Nov <strong>2011</strong> will be the<br />

last <strong>PSUR</strong> BMS will submit<br />

Cephapirin is no longer registered in the<br />

EU by BMS<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 13/61

283<br />

284<br />

285<br />

286<br />

287<br />

288<br />

289<br />

290<br />

291<br />

292<br />

293<br />

294<br />

295<br />

296<br />

297<br />

298<br />

299<br />

300<br />

A B C D E F<br />

Active substance name (INN)<br />

2<br />

chloramphenicol +<br />

281 dexamethasone<br />

chloramphenicol + hydrocortisone<br />

282 (ocular)<br />

chloramphenicol + combinations<br />

not further specified<br />

chlordiazepoxide<br />

chlordiazepoxide + combinations<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Spersadex comp. 19640519 201405 Novartis<br />

Cortifenol H 19581106 201311 Novartis<br />

19600131 201201<br />

Librax, Limbitrol 201201<br />

Next DLP Firm's Name Comments<br />

201306 Pfizer<br />

Valeant Phamaceuticals<br />

Ltd<br />

Valeant Phamaceuticals<br />

Ltd<br />

chlorhexidine 19760811 201308 UCB<br />

chlorhexidine + cetrimonium 201308<br />

chlorhexidine + dexpanthenol 201310<br />

chlorhexidine + lidocaine<br />

chlorhexidine + neomycin<br />

201203<br />

<strong>2011</strong>12<br />

chlorhexidine + sodium fluoride 201406<br />

chlorhexidine + tolnaftate Mycil Powder 19910227 201210 Reckitt Benckiser<br />

chlormadinone 19741118 201211 Sanofi Aventis<br />

chlornitrofenol 201302<br />

chlorobutanol + levomenthol +<br />

thymol + pine oils + terpineol<br />

Karvol 201211<br />

chlorocresol <strong>2011</strong>12<br />

chlorocresol combinations <strong>2011</strong>12<br />

chloropuramine 201408<br />

chloropyramine 201408<br />

chloroquine 19460815 201208 Sanofi Aventis<br />

Marketed by Pfizer: only<br />

chloramphenicol sodium succinate<br />

28/09/1957 in Austria and 15/07/1955 in<br />

Mexico<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 14/61

2<br />

301<br />

302<br />

303<br />

304<br />

305<br />

306<br />

307<br />

308<br />

309<br />

310<br />

311<br />

312<br />

313<br />

314<br />

315<br />

316<br />

317<br />

318<br />

319<br />

320<br />

321<br />

322<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

chlorothiazide 19571119 201311<br />

chloroxine 201408<br />

Next DLP Firm's Name Comments<br />

chloroxylenol Dettol Liquid 19330101 201304 Reckitt Benckiser<br />

chloroxylenol + disodium edetate<br />

chloroxylenol + edetic acid +<br />

triclosan<br />

Dettol Chelate 20021102 201304 Reckitt Benckiser<br />

Dettol Antiseptic Cream 20021102 201304 Reckitt Benckiser<br />

chlorphenamine 19540607 201310 Merck & Co.<br />

chlorphenamine combinations<br />

(except with dexchlorpheniramine)<br />

Many combinations and brand<br />

names<br />

201310<br />

chlorpropamide 19581119 201311<br />

chlortalidone 19590624 201306 Novartis<br />

chlortalidone + metoprolol Logroton 19781213 201212 Novartis<br />

chlortalidone + oxprenolol Trasitensin 19760927 201209 Novartis<br />

chlortalidone + reserpine Hygroton-Reserpine 19620206 201302 Novartis<br />

chlortetracycline 19499401 201203<br />

chlortetracycline +<br />

democlocycline + tetracycline<br />

19680401 201403<br />

chlorxylenol + dibucaine Xilen 201305 Recofarma s.r.l.<br />

chlorzoxazone 201205<br />

chlorzoxazone + paracetamol Parafon Forte 201205<br />

cholecalciferol concentrate +<br />

sodium fluoride Fluor-Vigantoletten 201212 Merck Serono<br />

choline salicylate 19631210 201303 Napp Pharmac.<br />

chondroitin <strong>2011</strong>11<br />

chondroitin + glucosamine Many <strong>2011</strong>11<br />

chromium ( 51 Cr) EDTA 19751130 <strong>2011</strong>11 GE Healthcare<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 15/61

2<br />

323<br />

324<br />

325<br />

326<br />

327<br />

328<br />

329<br />

330<br />

331<br />

332<br />

333<br />

334<br />

335<br />

336<br />

337<br />

338<br />

339<br />

340<br />

341<br />

342<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

cibenzoline 19831021 201210 BMS<br />

cicletanine 19860728 201201 Ipsen<br />

Next DLP Firm's Name Comments<br />

ciclopirox + oxolamine 19750402 201404 Sanofi Aventis<br />

cilastatin 201202<br />

cilazapril + hydrochlorothiazide Vascase Plus 19911228 <strong>2011</strong>12<br />

cilnidipine 19950929 201403 Bial<br />

cilostazol 201208<br />

cimetidine 19761109 <strong>2011</strong>11 GSK<br />

cimetidine + sodium alginate 19950424 <strong>2011</strong>11<br />

cinchocaine 201404<br />

cinnarizine 19611031 201210 J&J<br />

cinnarizine + piracetam 201210<br />

cinoxacin 19771128 <strong>2011</strong>11 Eli Lilly<br />

ciprofloxacine combinations 201301<br />

cisplatin<br />

19781219 201212<br />

citicoline 19661231 <strong>2011</strong>12 Takeda<br />

citral + terpinol + sylvestre pine oil<br />

+ serpolet oil<br />

Bronchorectine for infants,<br />

suppository<br />

201408 Mayoly Spindler<br />

citric acid + glycerol + honey +<br />

lemon oil + syrup Lemsip Cough Dry 201203 Reckitt Benckiser<br />

citric acid + magnesium sulfate +<br />

sodium bicarbonate<br />

citric acid + sodium bicarbonate +<br />

sodium carbonate<br />

201203<br />

201203<br />

The company BMS withdrew the<br />

innovator product. Substance moved<br />

from the WS list<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 16/61

2<br />

343<br />

344<br />

345<br />

346<br />

347<br />

348<br />

349<br />

350<br />

351<br />

352<br />

353<br />

354<br />

355<br />

356<br />

357<br />

358<br />

359<br />

360<br />

361<br />

362<br />

363<br />

A B C D E F<br />

Active substance name (INN)<br />

citric acide + sodium bicarbonate<br />

+ sodium carbonate + sodium<br />

citrate dihydrate<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

201203<br />

clavulanic acid 201309<br />

clemastine 201310 Novartis<br />

clemastine + dexamethasone <strong>2011</strong>09 Novartis<br />

clenbuterol<br />

19801212 201309 Boehringer Ingelheim<br />

clindamycin 19691016 201210 Pfizer<br />

clobazam 19700206 201302 Sanofi Aventis<br />

clobetasol 19730221 201302 GSK<br />

clobetasone 19750917 201209 GSK<br />

clobutinol 201304<br />

clofazimine 19690424 201304 Novartis<br />

clofibrate 201212<br />

clomethiazole 19591101 201210 AstraZeneca<br />

clomiphene 19620401 201304 Sanofi Aventis<br />

clomipramine 19651018 <strong>2011</strong>10 Novartis<br />

clonidine 201405<br />

clonixin 19750228 201302 Sanofi Aventis<br />

clopamide + dihydroegocrystine +<br />

reserpine<br />

Brinerdin 19660430 201204 Novartis<br />

clopamide + pindolol Viskaldix <strong>2011</strong>11 Novartis<br />

cloperastine 19810812 201407 Zambon<br />

clorazepate 19660803 201208 Sanofi Aventis<br />

Substance transferred from the WS list<br />

as the innovator product is not<br />

authorised in AT any longer (former P-<br />

RMS)<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 17/61

2<br />

364<br />

365<br />

366<br />

367<br />

368<br />

369<br />

370<br />

371<br />

372<br />

373<br />

374<br />

375<br />

376<br />

377<br />

378<br />

379<br />

380<br />

381<br />

382<br />

383<br />

384<br />

385<br />

A B C D E F<br />

Active substance name (INN)<br />

clorazepate + pyridonine<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

cloroxine 201211<br />

Next DLP Firm's Name Comments<br />

19730202 201208 UCB Innovator product from UCB withdrawn<br />

clothiapine 19660615 201206 Novartis<br />

clotrimazole 201209<br />

clotrimazole + dexamethasone 201209<br />

clotrimazole + hydrocortisone 201209<br />

clotrimazole + zinc oxide 201209<br />

cloxacillin<br />

19620105 201201 BMS<br />

clozapine 19691024 201210 Novartis<br />

coal tar 201406<br />

coal tar + menthol 19740101 201206 Pfizer<br />

coal tar derivative 201406<br />

coal tar + alcoholic extract 201406<br />

coal tar + soya oil 201406<br />

cobamamide 19691127 201312 Recordati S.p.A.<br />

cocaine 201212<br />

cod liver oil 201304<br />

cod liver oil + zinc oxide 19450411 201304 Sanofi Aventis<br />

co-danthrusate 19911126 201404 Recipharm<br />

codeine 19540906 <strong>2011</strong>09<br />

codeine polysulfonate +<br />

phenyltoloxamine polysulfonate<br />

codeine polysulfonate +<br />

phenyltoloxamine + guaifenesin<br />

Codipront 19660808 <strong>2011</strong>09<br />

Codipront Retard Cum<br />

Expectorans<br />

19730116 <strong>2011</strong>09<br />

<strong>PSUR</strong> with DLP Jan 2012 will be the last<br />

<strong>PSUR</strong> BMS will submit<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 18/61

2<br />

386<br />

387<br />

388<br />

389<br />

390<br />

391<br />

392<br />

393<br />

394<br />

395<br />

396<br />

397<br />

398<br />

399<br />

400<br />

401<br />

402<br />

403<br />

404<br />

405<br />

406<br />

407<br />

A B C D E F<br />

Active substance name (INN)<br />

codeine polysulfonate +<br />

phenyltoloxamine + guaifenesin +<br />

thyme<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Codipront Retard Cum<br />

Expectorans<br />

Proposed EU<br />

harmonised birth<br />

date<br />

19700911 <strong>2011</strong>09<br />

codeine polysulfonate resin Codipront Mono 19750217 <strong>2011</strong>09<br />

Next DLP Firm's Name Comments<br />

codeine + chlorpheniramine +<br />

ephedrine<br />

Corex <strong>2011</strong>09<br />

codeine + creosote Optrex Linetus <strong>2011</strong>09 Reckitt Benckiser<br />

codeine + diclofenac Combaren 19920707 201209 Novartis DLP aligned with diclofenac<br />

codeine + diphenhydramine <strong>2011</strong>09<br />

codeine + erysimum Euphon, syrup <strong>2011</strong>09 Mayoly Spindler<br />

codeine + guaifenesin + ephedrine<br />

hydrochloride<br />

codeine + ibuprofen<br />

<strong>2011</strong>09<br />

Ardinex 19930305 201303<br />

codergocrine 201204 Novartis<br />

colchicine<br />

19470730 201307<br />

Sanofi Aventis /<br />

Opocalcium lab<br />

colchicine + tiemonium + opium Colchimax, tablet 201307 Opocalcium lab<br />

colecalciferol + calcium Calcidose VIT.D, sachet 201310 Opocalcium lab<br />

colestipol 19760625 201306 Pfizer<br />

colestyramine 19650402 201204 BMS<br />

colistimethate 19621008 201312 Grünenthal<br />

colistine 19560623 201312<br />

collagenase 19691212 201312 Abbott<br />

comfrey extract+methylnicotinate<br />

comfrey root liquid extract<br />

(symphytum officinalis)<br />

Kytta-Balsam F <strong>2011</strong>12 Merck Serono<br />

Kytta <strong>2011</strong>12 Merck S.A<br />

cortisone 19520618 201208 Sanofi Aventis<br />

cortivazol 19700501 201304 Sanofi Aventis<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 19/61

2<br />

408<br />

409<br />

410<br />

411<br />

412<br />

413<br />

414<br />

415<br />

416<br />

417<br />

418<br />

419<br />

420<br />

421<br />

422<br />

423<br />

424<br />

425<br />

426<br />

427<br />

428<br />

429<br />

430<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

cotrimoxazole 19690401 201204 Roche<br />

Next DLP Firm's Name Comments<br />

cromoglicic acid 19690201 201202 Sanofi Aventis<br />

crotamiton 201307<br />

cyamemazine 19710614 201212 Sanofi Aventis<br />

cyanocobalamin ( 57 Co)<br />

<strong>2011</strong>10<br />

cyclizine 201301<br />

cyclopenthiazide<br />

19610111 201401<br />

cyclopentolate 19570219 201402 Alcon<br />

cyclophosphamide 19581013 201402 Baxter<br />

cyproheptadine 19611221 <strong>2011</strong>12 MSD<br />

cyproterone 201305 Bayer Schering<br />

cyproterone + ethinylestradiol<br />

201305 Bayer Schering<br />

cytarabine 19690916 201404 Pfizer<br />

cytidine diphosphate choline 20050601 201210<br />

dacarbazine 19780201 201302<br />

dactinomycin<br />

19630701 201206 Lundbeck<br />

danazol 19740610 201206 Sanofi Aventis<br />

dantrolene 19740131 201201 Procter & Gamble<br />

dantrone + poloxomer Co-danthramer 19880809 201304 Napp Pharmac.<br />

dapiprazole 19850806 201210 Acraf<br />

dapsone 201305<br />

dapsone + ferrous oxalate 19740101 201305 Sanofi Aventis<br />

decamethrin + piperonyl 201306<br />

Innovator product by Novartis<br />

deregistered<br />

Active substance divested from MSD to<br />

Lundbeck<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 20/61

2<br />

431<br />

432<br />

433<br />

434<br />

435<br />

436<br />

437<br />

438<br />

439<br />

440<br />

441<br />

442<br />

443<br />

444<br />

445<br />

446<br />

447<br />

448<br />

449<br />

450<br />

451<br />

452<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

deferoxamine 19621201 <strong>2011</strong>12 Novartis<br />

Next DLP Firm's Name Comments<br />

deflazacort 19820326 201203 Sanofi Aventis<br />

dehydrocholic acid 201306<br />

delapril 19890117 201201 Takeda<br />

delapril + manidipine 19890117 201206 Takeda<br />

delorazepam 201308<br />

deltamethrin 201407<br />

demeclocycline 19670823 201206<br />

demoxytocin 201312 JSC Grindeks<br />

dequalinium chloride 201207<br />

dequalinium chloride + lidocaine 19620601 201207 Sanofi Aventis<br />

desipramine<br />

deslanoside<br />

desmopressin<br />

196<strong>2011</strong>5 201202<br />

19381215 201203<br />

19721200 <strong>2011</strong>12<br />

desonide 201308<br />

Ferring Pharmaceuticals<br />

AS<br />

desoximetasone 19680123 201207 Sanofi Aventis<br />

desoxycortone acetate 19570101 201304 Sanofi Aventis<br />

detajmium 19760415 <strong>2011</strong>11 AWD<br />

dexamethasone 19520101 201401 Alcon<br />

dexamethasone + framycetin +<br />

gramicidin<br />

SOFRAMYCINE /<br />

SOFRAMYCINE<br />

HYDROCORTISONE /<br />

SOFRADEX / SOFRACORT<br />

19540810 201401 Sanofi Aventis<br />

dexamethasone + neomycin 19590831 201401<br />

dexamethasone + neomycin +<br />

polymyxin b<br />

Maxitrol 19520101 201401 Alcon<br />

Innovator product by Novartis<br />

deregistered<br />

Innovator product by Novartis<br />

deregistered<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 21/61

458<br />

459<br />

460<br />

461<br />

462<br />

463<br />

464<br />

465<br />

466<br />

467<br />

468<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

2<br />

453<br />

dexamethasone + neomycin +<br />

acetic acid, glacial<br />

201401<br />

454<br />

dexamethasone + polymyxin b +<br />

trimethoprim<br />

Otix 19520101 201401 Alcon<br />

455<br />

dexamethasone sodium<br />

phosphate<br />

19590601 201401<br />

456<br />

dexamethasone + tobramycin<br />

(ophtalmic and otic use)<br />

201403 Alcon<br />

457 dexamphetamine 19921013 201304 Auden McKenzie<br />

dexbrompheniramine<br />

combinations Drixoral / Disophrol 19730210 201306 Merck & Co.<br />

dexchlorpheniramine 19620218 201206 Merck & Co.<br />

dexchlorpheniramine +<br />

chlorphenamine +<br />

pseudoephedrine<br />

dexchlorpheniramine +<br />

dextromethorphan + coffein<br />

Demazin 19620218 201306 Merck & Co.<br />

Coricidin 19620218 201306 Merck & Co.<br />

dexchlorpheniramine +<br />

pseudoephedrine<br />

dexchlorpheniramine +<br />

Demazin / Polaramine<br />

Expectorant<br />

19620218 201206 Merck & Co.<br />

pseudoephedrine + guaiafenesin Polarimix 19620218 201206 Merck & Co.<br />

dexetimide<br />

dexfenotrine + piperonyl butoxide<br />

dexpanthenol<br />

19711001 201310<br />

19910423 201204<br />

201310<br />

dextran (40, 60 and 70) 201308<br />

dextran 1 201308<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 22/61

2<br />

469<br />

470<br />

471<br />

472<br />

473<br />

474<br />

475<br />

476<br />

477<br />

478<br />

479<br />

480<br />

481<br />

482<br />

483<br />

484<br />

485<br />

486<br />

487<br />

488<br />

489<br />

A B C D E F<br />

Active substance name (INN)<br />

dextran 70 + hydroxypropylmethyl<br />

cellulose<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Tears Naturale 19760501 201405 Alcon<br />

dextranomer 201309<br />

dextrometorphan 19660101 201406<br />

dextrometorphan combinations<br />

(except with chlorphenamine,<br />

dexchlorpheniramine or<br />

paracetamol)<br />

RHINATHIOL<br />

TOUX SECHE /<br />

TUSSORHINATHIOL<br />

Next DLP Firm's Name Comments<br />

19671215 201406 Sanofi Aventis<br />

diacethylmorphine 201310<br />

diazepam 19631129 201202 Roche<br />

diazepam + pyridoxine 19660404 201202<br />

diazoxide 19721229 201304 Merck & Co.<br />

dibenzepine 19640515 201205 Novartis<br />

dibromopropamidine 19590116 201401 Sanofi Aventis<br />

dibucaine 201311<br />

diclofenac + gentamicin Voltamicin 19960920 201209<br />

dicloxacillin 19610224 201202 BMS<br />

dicycloverine 201402<br />

diethylamine salicylic acid<br />

combinations<br />

Algesal Forte 19671120 <strong>2011</strong>11 Abbott<br />

diethylcarbamazine 19740109 201208 Sanofi Aventis<br />

diethylstilbestrol 201401<br />

digitoxin 19520911 201203 Merck Serono<br />

digoxin 19301101 201310 GSK<br />

dihydralazine<br />

dihydralazine +<br />

hydrochlorothiazide + reserpine<br />

19530323 201203<br />

Adelphan-Esidrex 19590615 201406 Novartis<br />

The innovator product from Novartis is<br />

globally deregistered<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 23/61

2<br />

490<br />

491<br />

492<br />

493<br />

494<br />

495<br />

496<br />

497<br />

498<br />

499<br />

500<br />

501<br />

502<br />

503<br />

504<br />

505<br />

506<br />

507<br />

508<br />

509<br />

510<br />

511<br />

512<br />

513<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

dihydrocodeine 19211111 <strong>2011</strong>11 Abbott<br />

dihydrocodeine combinations<br />

Next DLP Firm's Name Comments<br />

<strong>2011</strong>11<br />

dihydroergocristine + esculinum +<br />

rutoside<br />

Anavenol 201402<br />

dihydroergotamine 19460701 201204 Novartis<br />

dihydroergotamine + etilefrine Dihydergot Plus 19820319 201303 Novartis<br />

dihydroergotoxin +<br />

hydrochlorothiazide + reserpine<br />

201204<br />

dihydrotachysterol 19590401 201303 Merck Serono<br />

diiodhydroxyquinoline 201403<br />

diisopropylamine 201405<br />

dimefline 19740412 201312 Recordati S.p.A.<br />

dimenhydrinate 19500210 201210 Bracco<br />

dimercaptosuccinic acid (DMSA)<br />

dimethindene<br />

19820531 201205<br />

201304 Novartis<br />

dimethoxanate 19610301 201405 Sanofi Aventis<br />

dimethyl sulfoxide 201406<br />

dimeticone 19651117 201404 Pfizer<br />

dimeticone combinations Pepsane, Vingel 201404<br />

dinoprost trometamol Minprostin F2 Alpha Amp. 19730508 201305<br />

dinoprostone 19720926 201309 Pfizer<br />

diosmectite 19751112 201311 IPSEN<br />

diosmine 201305<br />

diosmine + hesperidine 201203<br />

diphemanile 19630927 201408 Merck & Co.<br />

diphenhydramine 201203<br />

Covidien to confirmed whether it is the<br />

innovator company<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 24/61

2<br />

514<br />

515<br />

516<br />

517<br />

518<br />

519<br />

520<br />

521<br />

522<br />

523<br />

524<br />

525<br />

526<br />

527<br />

528<br />

529<br />

530<br />

531<br />

532<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

diphenhydramine combinations<br />

(except with paracetamol)<br />

201203<br />

dipivefrin 19780919 201309 Allergan<br />

dipyridamole<br />

Next DLP Firm's Name Comments<br />

19591111 201312 Boehringer Ingelheim<br />

dirithromycin 19930426 201204 Eli Lilly<br />

disopyramide 19670418 201404 Sanofi Aventis<br />

distigmine 19790401 201204 Sanofi Aventis<br />

disulfiram 19710304 201403 Sanofi Aventis<br />

dixyrazine 19610401 201204<br />

DL-Methionine, L-Cystine, Calcium<br />

panthotenate, Thiamine HCl,<br />

Pyridoxine HCl, Paraaminobenzoic<br />

Acid, Chelated Minerals-Zn, Fe,<br />

Cu, Millet Extract, Wheat germ<br />

extract, Barm Yeast<br />

19880601 201306<br />

dobesilate calcium 201307<br />

Ewopharma International<br />

Ltd.<br />

dobutamine 19770321 201203 Eli Lilly<br />

docusate 201211<br />

domiphen<br />

dopamine 19751009 <strong>2011</strong>10<br />

201312 Novartis<br />

dopexamine 19891113 <strong>2011</strong>09 Cephalon<br />

dornase alfa + fibrinolysin Fibrolan 19630610 201304 Pfizer<br />

dornase alfa + fibrinolysin +<br />

chloramphenicol<br />

Fibrase 19620423 201304<br />

dosulepin (dothiepin) 19730417 201404 Abbott<br />

doxapram hydrochlorid 19671218 201312 Eumedica<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 25/61

2<br />

533<br />

534<br />

535<br />

536<br />

537<br />

538<br />

539<br />

540<br />

541<br />

542<br />

543<br />

544<br />

545<br />

546<br />

547<br />

548<br />

549<br />

550<br />

551<br />

552<br />

553<br />

554<br />

555<br />

556<br />

557<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

doxepin 19690801 201203 Pfizer<br />

doxorubicine 19711015 201210 Pfizer<br />

doxycycline 19670505 201305 Pfizer<br />

Next DLP Firm's Name Comments<br />

doxylamine 201402 Bayer Schering<br />

drofenine + propyphenazone Spasmo-Cibalgin 19370727 201408 Novartis<br />

droperidol 19630420 201304 Pro Strakan<br />

droperidol + fentanyl Thalamonal 19740814 201304<br />

dropropizine 201407<br />

drotaverin 19621229 201312 Sanofi Aventis<br />

dydrogesterone 19600422 201404 Abbott<br />

eberconazole 20040300 201201 SALVAT<br />

eflornithine 19900101 201308 Sanofi Aventis<br />

embramine 201408<br />

enflurane 19720429 201404 Abbott<br />

enoxaparin 19870403 201204 Sanofi Aventis<br />

enoximone 19871027 201210 Sanofi Aventis<br />

enoxolone 19880928 201401<br />

epervudine 201408<br />

ephedrine 201206<br />

ephedrine combinations (except<br />

with chlorphenamine)<br />

201206<br />

epitizide + triamterene <strong>2011</strong>11<br />

erdosteine 201408 Edmond Pharma<br />

ergometrine <strong>2011</strong>11<br />

ergometrine + oxytocin Syntometrine 19600615 201406 Novartis / Alliance<br />

erwinia asparaginase 19850719 201312 EUSA<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 26/61

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

2<br />

558 erythromycin 19540311 201203 Amdipharm<br />

559 esbiothrin 201309 Bayer Schering<br />

560 escherichia coli asparaginase 19971231 201307 EUSA<br />

561 esculoside 201204<br />

562 esmolole 19861231 <strong>2011</strong>12 Baxter<br />

563 estazolam 19750430 201204 Takeda<br />

564<br />

estradiol (17-beta) + gestodene 20011227 <strong>2011</strong>12<br />

565 estradiol + testosterone Estandron prolongatum 19760301 201402 Organon<br />

566 estradiol + dydrogesterone Femoston 19950222 201402 Abbott<br />

567 estramustine 19710902 201405 Pfizer<br />

568 estriol Ovestin 19570101 201312 Organon<br />

569 estrogens, conjugated 19420508 201305 Pfizer<br />

570 estropipate Ogen 0.625 19770519 201205<br />

571<br />

etacrynic acid 19650514 201205 Aton<br />

572 etamsylate 19870422 201404 Sanofi Aventis<br />

573 ethambutol 19581017 201207<br />

574 ethambutol + isoniazid 19710903 201209<br />

575<br />

ethambutol + isoniazid +<br />

rifampicine<br />

19980402 201204<br />

ethambutol + isoniazid +<br />

576<br />

pyrazinamid + rifampicine 19980402 201204<br />

577 ethyl loflazepate 19801103 201211 Sanofi Aventis<br />

578 ethinylestradiol Lynoral 19760601 201210 Organon<br />

579<br />

ethinylestradiol + norelgestromin<br />

201211 J&J<br />

580<br />

ethinylestradiol + norethisterone<br />

201208 J&J<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 27/61

2<br />

581<br />

582<br />

583<br />

584<br />

585<br />

586<br />

587<br />

588<br />

589<br />

590<br />

591<br />

592<br />

593<br />

594<br />

595<br />

596<br />

597<br />

A B C D E F<br />

Active substance name (INN)<br />

etidronate<br />

estradiol (17-beta) + norgestimate<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

19770930 201209 Procter & Gamble<br />

Prefest 201210 J&J<br />

ethionamide 19610608 201406 Sanofi Aventis<br />

ethosuximide 19610309 201206 Pfizer<br />

ethyl esters of iodised fatty acids<br />

from poppyseed oil<br />

ethinylestradiol + lynestrenol<br />

etilefrine<br />

Lipiodol Ultra-Fluid<br />

Lipiodol 190<br />

19890331 201301 Gerbet<br />

Restovar 19730330 201303 Organon<br />

19520417 201312 Boehringer Ingelheim<br />

etodolac 19840802 201208 Pfizer<br />

etofenamate 201306<br />

etofylline 201211<br />

etoperidone 19760211 201210 Acraf<br />

etynodiol 19721025 201202 Pfizer<br />

etynodiol + ethinylestradiol Demulen 1/50-28 19700424 201202<br />

etynodiol + mestranol Metrulen 19650212 201202<br />

eucalyptol 201209<br />

eucalyptol combinations 201209<br />

felbinac<br />

19860925 201209 Pfizer<br />

The innovator product has been<br />

withdrawn from the Danish market (P-<br />

RMS). The substance has therefore<br />

been transferred from the WS list<br />

The innovator product from Pfizer is<br />

approved in DE only<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 28/61

2<br />

598<br />

599<br />

600<br />

601<br />

602<br />

603<br />

604<br />

605<br />

606<br />

607<br />

608<br />

609<br />

610<br />

611<br />

612<br />

613<br />

614<br />

615<br />

616<br />

617<br />

A B C D E F<br />

Active substance name (INN)<br />

felodipine + metoprolol<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

Logimax 19921231 201212 AstraZeneca<br />

fenbufen 19710827 201408<br />

fenofibrate 19741104 201407<br />

fenoldopam 201212<br />

fenoprofen 201301<br />

fenoterol<br />

201302 Boehringer Ingelheim<br />

fenspiride 19931208 201404 Servier<br />

fenticonazole 19860416 201312 Recordati S.p.A.<br />

ferric hydroxide polymaltose<br />

complex + folic acid<br />

Maltofer Fol/ Ferrum Fol<br />

Hausmann<br />

19640207 201208 Vifor<br />

ferric gluconate salts 201208<br />

ferric hydroxide polymaltose<br />

complex<br />

19640207 201208 Vifor<br />

ferric salts + folic acid 201208<br />

ferrous fumarate 19700119 201408 Vifor<br />

ferrous salts 19490101 201201 Sanofi Aventis<br />

ferrous glycine sulphate + folic<br />

acid<br />

Ferro Gyn 19990330 201201 UCB<br />

flavodate 19910111 201204 UCB<br />

flavoxate 19670804 201312 Recordati S.p.A.<br />

floctafenine 19720705 201407 Sanofi Aventis<br />

fluanisone 19861001 201310 Sanofi Aventis<br />

flucinolone acetonide + neomycin<br />

sulphate<br />

Synalar N Cream and Synalar<br />

N Ointment<br />

201312 GP Pharma Ltd<br />

Combination moved from the WS list as<br />

the innovator product was withdrawn<br />

from DK (P-RMS)<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 29/61

2<br />

618<br />

619<br />

620<br />

621<br />

622<br />

623<br />

624<br />

625<br />

626<br />

627<br />

628<br />

629<br />

630<br />

631<br />

632<br />

633<br />

634<br />

635<br />

636<br />

637<br />

638<br />

639<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

flucloxacillin 19700303 201203 GSK<br />

flucytosine<br />

19751001 201209<br />

Next DLP Firm's Name Comments<br />

Valeant Phamaceuticals<br />

Ltd<br />

fludrocortisone 19541028 201310 BMS<br />

fludrocortisone + gramicidin +<br />

neomycin<br />

<strong>2011</strong>12<br />

fluindione 19690902 <strong>2011</strong>09 Procter & Gamble<br />

flumetasone 19640101 201406 Novartis<br />

flumetasone + clioquinol Locacorten Vioform 19660215 201406 Novartis<br />

flunisolide 19820825 201312 Recordati S.p.A.<br />

fluocinolone acetonide (incl.<br />

acetate ester fluocinonide)<br />

fluocinolone acetonide +<br />

clioquinol<br />

fluocinolone acetonide + lidocaine<br />

19650226 201312 Recordati S.p.A.<br />

201312<br />

201203<br />

fluocinolone + metronidazole +<br />

nystatin<br />

<strong>2011</strong>11 Bayer Schering<br />

fluorescein 19610412 201404 Alcon<br />

fluorescein + oxybuprocaine Colircusi Fluotest 19610412 201404 Alcon<br />

fluoride 201201<br />

fluoride sodium + strontium<br />

acetate hemihydrate<br />

201406<br />

fluoride + malic acid 201201<br />

fluoride + monofluorophosphate 201201 Procter & Gamble<br />

fluorometholone 19720414 201307 Allergan<br />

fluorometholone + gentamicin Infectoflam 19940101 201312 Novartis<br />

fluorometholone + tetryzoline Efemoline 19771019 201310 Novartis<br />

fluorouracil 19771216 <strong>2011</strong>12 Pfizer<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 30/61

2<br />

640<br />

641<br />

642<br />

643<br />

644<br />

645<br />

646<br />

647<br />

648<br />

649<br />

650<br />

651<br />

652<br />

653<br />

654<br />

655<br />

656<br />

657<br />

658<br />

659<br />

660<br />

661<br />

662<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

flupentixol 19651130 201311 Lundbeck<br />

flupentixol + melitracene Deanxit 19710131 201311 Lundbeck<br />

fluphenazine 19591218 201212 BMS<br />

flupirtine 19891024 201202 AWD<br />

fluprednidene + miconazole<br />

flurazepam<br />

19730302 201203<br />

fluspirilene 201206<br />

Next DLP Firm's Name Comments<br />

201402 Almirall Hermal<br />

Valeant Phamaceuticals<br />

Ltd<br />

folic acid 19471213 201206 Sanofi Aventis<br />

folic acid + nicotinamide 201206<br />

fomepizole 20000921 201404 EUSA FR is the RMS<br />

fosphenytoin 19960805 201408 Pfizer<br />

fotemustine 19890414 201408 Servier<br />

framycetin 201202<br />

fructose + glucose + xylitol Kaloricna raztopina 201402 Pliva<br />

fucidic acid 19620531 201309 LEO Pharma<br />

furazolidone 201310<br />

furosemide 19610101 201201 Sanofi Aventis<br />

furosemide combinations<br />

19610101 201201 Sanofi Aventis<br />

fusafungine 19950327 201312 Servier<br />

gadodiamide 19930201 201301 Ge Healthcare<br />

gadoxetic acid disodium 201403 Bayer Schering<br />

galactose + palmitic acid 19950621 201306 Bayer Schering<br />

galacturoglicano 19870730 201207<br />

This also includes amiloride +<br />

furosemide which has been deleted<br />

from the list to avoid confusions<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 31/61

2<br />

663<br />

664<br />

665<br />

666<br />

667<br />

668<br />

669<br />

670<br />

671<br />

672<br />

673<br />

674<br />

675<br />

676<br />

677<br />

678<br />

679<br />

680<br />

681<br />

682<br />

683<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

gallium ( 67 Ga) citrate 19720331 201203<br />

gallopamil 19861230 201312 Abbott<br />

ganciclovir 19880106 201306 Roche<br />

gelatin absorbable<br />

Next DLP Firm's Name Comments<br />

19471111 <strong>2011</strong>11 Pfizer<br />

gemfibrozil Lopid 19810601 201206 Pfizer<br />

gentamicin 19660907 201203 Merck Serono<br />

gestrinone 19830121 201301 Sanofi Aventis<br />

ginkgo biloba extract + heptaminol<br />

hydrochloride + troxerutin<br />

ginkgo biloba extract + troxerutin<br />

Ginkor Fort, Ginkor Procto,<br />

Perivar forte<br />

19740124 201401 IPSEN<br />

Ginkor Gel 19740124 201401 Ipsen<br />

glibenclamide (micro) Daonil N / Euglucon 19820218 201202 Sanofi Aventis<br />

glibenclamide (non micro) 19690205 201202 Sanofi Aventis<br />

glibornuride<br />

19710801 201307<br />

Valeant Phamaceuticals<br />

Ltd<br />

gliclazide 19720101 201402 Servier<br />

glipizide Glibenese 19711120 201301 Pfizer<br />

gliquidone<br />

Glurenorm 19690916 201408 Boehringer Ingelheim<br />

glucosamine 19960731 201203 Rottapharm S.p.A.<br />

glutethimide 19740415 201205<br />

glycerol 201205<br />

glycine 201307<br />

glycopyrronium (glycopyrrolate) 19610911 201209<br />

glycopyrronium (glycopyrrolate) +<br />

neostigmine<br />

Robinul-neostigmine 19920306 201209 Eumedica<br />

Pfizer does not plan to prepare a <strong>PSUR</strong><br />

as this substance is classified as device.<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 32/61

2<br />

684<br />

685<br />

686<br />

687<br />

688<br />

689<br />

690<br />

691<br />

692<br />

693<br />

694<br />

695<br />

696<br />

697<br />

698<br />

699<br />

700<br />

701<br />

702<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

gonadorelin 201311<br />

gramicidin <strong>2011</strong>12<br />

gramicidin, neomycin,<br />

naphazoline, phenylephrine<br />

Next DLP Firm's Name Comments<br />

Neo-priphen 19560517 <strong>2011</strong>12 Minerva Pharmaceutical<br />

gramicidin + neomycin Graneodin 19530204 <strong>2011</strong>12 BMS<br />

griseofulvin 19590716 201307 GSK<br />

guaifenesin 19490531 201205 Pfizer<br />

guaifenesin + pseudoephedrine 201205 GSK<br />

guaifenesin + pseudoephedrine +<br />

triprolidine<br />

halcinonide<br />

haloperidol, haloperidol<br />

decanoate, haloperidol buzepide<br />

Haldol, Haldol Decanoas,<br />

Vesadol<br />

201205 GSK<br />

19730514 201205 BMS<br />

19600424 201401 J&J<br />

halothane 201407<br />

heparin Heparin 19390331 201203 Sanofi Aventis<br />

heparin combinations 201203<br />

heparinoid<br />

19910101 201001 Bayer Schering<br />

heparinoid + ibuprofen 201301<br />

heptaminol 19650128 201201 Sanofi Aventis<br />

hexamidine Hexomedine<br />

hexamidine + isetionate +<br />

lidocaine hydrochloride<br />

19510329 201209 Sanofi Aventis<br />

19510329 201209 Sanofi Aventis<br />

hexamidine + tetravacaine 19510329 201209 Sanofi Aventis<br />

<strong>PSUR</strong> with DLP May 2012 will be the<br />

last <strong>PSUR</strong> BMS will submit<br />

An input is sought regarding the next<br />

DLP<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 33/61

2<br />

703<br />

704<br />

705<br />

706<br />

707<br />

708<br />

709<br />

710<br />

711<br />

712<br />

713<br />

714<br />

715<br />

716<br />

717<br />

718<br />

719<br />

720<br />

721<br />

722<br />

A B C D E F<br />

Active substance name (INN)<br />

hexaminolevulinate hydrochloride<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

20040917 201203 GE Healthcare<br />

hexetidine 201307<br />

hexylresorcinol <strong>2011</strong>10 Reckitt Benckiser<br />

human chorionic gonadotropin<br />

(HCG)<br />

Pregnyl 19320630 201306 Organon<br />

hyaluronate sodium 201408<br />

hyaluronate zinc 19960102 201408 Gedeon Richter<br />

hyaluronidase 19600531 201205 Sanofi Aventis<br />

hydralazine Apresoline<br />

(tabs+amps)<br />

19520313 201303 Novartis<br />

hydrochlorothiazide<br />

Esidrex 19581222 201212 Novartis<br />

hydrochlorothiazide + triamterene<br />

hydrochlorothiazide + metoprolol<br />

201209<br />

Selozide, Selokomb 19780511 201202 AstraZeneca<br />

hydrochlorothiazide + propranolol<br />

+ triamterene<br />

201209<br />

hydrochlorothiazide + reserpine +<br />

triamterene<br />

201209<br />

hydrocortisone 19520805 201408<br />

hydrocortisone + lidocaine Xyloproct 19500101 201212 AstraZeneca<br />

hydrocortisone + oxytetracycline<br />

201305<br />

hydrocortisone + urea 201212<br />

hydrocortisone acetate +<br />

neomycine + centella extract<br />

201402<br />

hydromorphone 19981125 201211<br />

hydromorphone + atropine Dilaudid-atropin 19350321 201211 Mundipharma<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 34/61

2<br />

723<br />

724<br />

725<br />

726<br />

727<br />

728<br />

729<br />

730<br />

731<br />

732<br />

733<br />

734<br />

735<br />

736<br />

737<br />

738<br />

739<br />

740<br />

741<br />

742<br />

743<br />

744<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

hydroxychloroquine 19550418 201204 Sanofi Aventis<br />

hydroxycobalamin 19921014 201309 Recipharm<br />

hydroxyethylsalicylate 201204<br />

hydroxyurea (hydroxycarbamide) 19660322 201203 BMS<br />

hymecromone 19650727 201307 Merck Serono<br />

hyoscine 19520101 201406<br />

hypericin 19990901 201209<br />

hypochlorite sodium 201408 AMUCHINA S.p.A.<br />

hyprolose<br />

19800610 201306<br />

hypromellose 201212 Novartis<br />

ibopamine<br />

ibuprofen<br />

19840403 201408<br />

19690219 201402<br />

Abbott / Reckitt<br />

Benckiser<br />

ibuprofen + lysine <strong>2011</strong>09 Reckitt Benckiser<br />

ibuprofen + pseudoephedrine 19890918 201307 Pfizer<br />

ichthyol (ammonium<br />

ichthosulfonate)<br />

201309 Abbott<br />

idebenone 19860930 <strong>2011</strong>09 Takeda<br />

idoxuridine 19781120 <strong>2011</strong>11 Sanofi Aventis<br />

ifenprodil 19740306 201303 Sanofi Aventis<br />

ifosfamide 19760713 201307 Baxter<br />

123 I-hippuran 19960119 201301<br />

125 I-human serum albumin 19891215 201211<br />

123I-MIBG 19950131 201301 GE Healthcare<br />

Deletion of the Marketing Authorisation<br />

of the innovator MSD in EEA.<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 35/61

2<br />

745<br />

746<br />

747<br />

748<br />

749<br />

750<br />

751<br />

752<br />

753<br />

754<br />

755<br />

756<br />

757<br />

758<br />

759<br />

760<br />

761<br />

762<br />

763<br />

764<br />

765<br />

766<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

imidapril 19931001 <strong>2011</strong>09<br />

imipramine 19580313 201203 Novartis<br />

indapamide 20020225 201211 Servier<br />

indomethacin<br />

Next DLP Firm's Name Comments<br />

19630622 201206 Iroko / Lundbeck<br />

inosine 201306<br />

insulin human 19801026 <strong>2011</strong>10 Eli Lilly<br />

iodamide 19690926 201210 Bracco<br />

iodate 201207<br />

iodide 201204<br />

iodide ( 131 I) sodium 19731001 <strong>2011</strong>09 GE Healthcare<br />

iodine 201207<br />

iotalamic acid 19650313 201210 Bracco<br />

iotrolan 19870630 <strong>2011</strong>11 Bayer Schering<br />

ioxitalamic acid Telebrix 12 Na, Telebrix 35,<br />

Telebrix 30M, Telebrix<br />

Hystero, Telebrix Gastro<br />

19740430 201408 Guerbet<br />

ipecacuanha + combinations 201408<br />

ipratropium<br />

ipratropium + salbutamol 201401<br />

isoniazid 19730228 <strong>2011</strong>11<br />

isoniazide + pyrazinamide +<br />

rifampicin<br />

19740814 201311 Boehringer Ingelheim<br />

Rifater 19680501 201305 Sanofi Aventis<br />

isoniazide + rifampicin Rifinah 19680501 201305 Sanofi Aventis<br />

isoprenaline 19770404 201209<br />

isosorbide dinitrate 19630917 201309<br />

Active substance divested from MSD to<br />

Iroko (oral formulation) and Lundbeck<br />

(intravenous formulation)<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 36/61

2<br />

767<br />

768<br />

769<br />

770<br />

771<br />

772<br />

773<br />

774<br />

775<br />

776<br />

777<br />

778<br />

779<br />

780<br />

781<br />

782<br />

783<br />

784<br />

785<br />

786<br />

787<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

isosorbide mononitrate 19800501 <strong>2011</strong>12<br />

ispaghula husk + mebeverine 201302<br />

itopride 19950630 201306 Abbott<br />

josamycin 19700300 201203<br />

ketamine Ketolar 19681210 201212 Pfizer<br />

Next DLP Firm's Name Comments<br />

ketocaine + fluocinonide Proctonide 19831006 201312 Recordati S.p.A.<br />

klebsiella pneumonia<br />

glycoproteins<br />

19770704 201207 Sanofi Aventis<br />

ketocaine hydrochloride +<br />

fluocinolone acetonide<br />

Proctolyn 19690908 201312 Recordati S.p.A.<br />

l-acetyl carnitine 19840601 201206 Sigma-Tau<br />

lactobacillus LB 19780502 201405 Axcan Pharma<br />

lactulose 19640521 201405 Abbott<br />

lansoprazole 19901231 <strong>2011</strong>12 Takeda<br />

lauromacrogol 400 Aethoxysklerol 19660525 201403 Kreussler&Co. GmbH<br />

lauromacrogols combinations 201403<br />

leuprorelin 19840731 201207 Takeda<br />

levodropropizine<br />

levonorgestrel (oral formulations)<br />

19970508 201205<br />

201312 Gedeon Richter<br />

levomepromazine 19560704 201206 Sanofi Aventis<br />

levosulpiride 19860401 201403 Abbott<br />

lidocain + zinc oxide 19911121 201212<br />

Alternative Brand Names =<br />

Biostim/Biostim pro deti<br />

Substance transferred from the WS list<br />

as the marketing authorisations currently<br />

existing in HU (previously assigned as P-<br />

RMS) are going to be cancelled.<br />

lidocaine 19481001 201212 Astrazeneca LA topical<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 37/61

2<br />

788<br />

789<br />

790<br />

791<br />

792<br />

793<br />

794<br />

795<br />

796<br />

797<br />

798<br />

799<br />

800<br />

801<br />

802<br />

803<br />

804<br />

805<br />

806<br />

807<br />

808<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

lidocaine 19481001 201309 AstraZeneca LA inj. + cardio inj.<br />

lidocaine + adrenaline Xylocaine-Adrenaline 19481001 201309 Astrazeneca LA inj.<br />

lidocaine hydrochloride +<br />

chlorhexidine hydrochloride<br />

Cathejell Lidocain 19900824 201212 Montavit<br />

lidocaine + tetracaine Pliaglis 20060629 201306 Zars Topical use<br />

lincomycin Lincocin 19600101 201201 Pfizer<br />

linsidomine 19871229 201212 Sanofi Aventis<br />

liothyronine 19971216 201212 Sanofi Aventis<br />

lithium 19670220 201302 GSK<br />

lodoxamide 19900702 201407 Alcon<br />

lofepramine 19760227 201301 Merck Serono<br />

lomefloxacin 19901212 201306 Pfizer<br />

lomefloxacin (ophtalmic<br />

preparations)<br />

19941005 201310 Novartis<br />

lonazolac 201406<br />

loprazolam<br />

19810710 201207 Sanofi Aventis<br />

loracarbef 19911231 201212 Eli Lilly<br />

lorazepam 19631231 201312 Pfizer<br />

Ioversol 19890601 201403 Covidien<br />

loxapine 19611220 201212<br />

l-propionyl carnitine 19941115 201312 Sigma-Tau<br />

l-tryptophan 201311<br />

lymecycline Tetralysal 19610131 201401 Galderma<br />

This substance was previously included<br />

in the WS list with CZ as P-RMS.<br />

However, it seems that the innovator<br />

product from Novartis is not authorised<br />

in CZ. Therefore, a new P-RMS is<br />

sought<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 38/61

2<br />

809<br />

810<br />

811<br />

812<br />

813<br />

814<br />

815<br />

816<br />

817<br />

818<br />

819<br />

820<br />

821<br />

822<br />

823<br />

824<br />

825<br />

826<br />

827<br />

828<br />

829<br />

830<br />

831<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

lynestrenol Exluton, Orgametril 19730320 201303 Organon<br />

Next DLP Firm's Name Comments<br />

lysine acetylsalicylic acid +<br />

metoclopramide<br />

Migpriv 19931208 201212 Sanofi Aventis<br />

macrogol 3350 19910415 201305 Norgine<br />

magaldrate 201407<br />

magnesium +/or calcium +/or<br />

aluminium antacids<br />

magnesium combinations<br />

(excluding antiacids)<br />

malathion<br />

201301<br />

201306<br />

19920304 201203 Sanofi Aventis<br />

manidipine 19900629 201206 Takeda<br />

mannitol 201402<br />

maprotiline Ludiomil 19700923 <strong>2011</strong>09 Novartis<br />

marine fish oil 201301<br />

mazindol Teronac/ Sanorex 19730615 201206 Novartis<br />

mebendazole 19710503 201305 J&J<br />

mebeverine 19641110 201302 Abbott<br />

mecillinam 19770531 201308 LEO Pharma<br />

meclofenamate Meclomen 19840926 201209<br />

meclozine 19530508 201308 UCB<br />

meclozine hydrochloride, fixed<br />

combinations<br />

19530508 201308 UCB<br />

medazepam 201308<br />

medroxyprogesterone acetate 19590820 201207 Pfizer<br />

mefenamic acid 19620328 201203 Pfizer<br />

mefruside + nifedipine 19840710 201207<br />

megestrol 19710818 201408 BMS<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 39/61

2<br />

832<br />

833<br />

834<br />

835<br />

836<br />

837<br />

838<br />

839<br />

840<br />

841<br />

842<br />

843<br />

844<br />

845<br />

846<br />

847<br />

848<br />

849<br />

850<br />

851<br />

852<br />

853<br />

854<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

meglumine 19470122 201401 Sanofi Aventis<br />

melarsoprol 19970502 201205 Sanofi Aventis<br />

meldonium 19880323 201308 JSC Grindeks<br />

melperone 19680117 201201 Swedish Orphan<br />

melphalan 19630926 <strong>2011</strong>09 GSK<br />

menthol 201208<br />

menotrophin<br />

201212<br />

Merck Serono / Organon<br />

/ Merck & Co.<br />

mepartricin 19740228 201211 SPA<br />

mephenesin 19750120 201301 Sanofi Aventis<br />

mephenoxalone 201402<br />

meprobamate 19630725 201310 Sanofi Aventis<br />

meprobamate + aceprometazine<br />

Mepronizine 19860913 201309 Sanofi Aventis<br />

mepyramine 19691231 201312 Sanofi Aventis<br />

mercaptopurine 19530911 <strong>2011</strong>09 GSK<br />

mesnum 19700801 201407 UCB<br />

metamizole 19230410 201204 Sanofi Aventis<br />

metamizole combinations 19230410 201204 Sanofi Aventis<br />

metformin + glibenclamide Glucovance 20011018 201207 Merck Sante<br />

methadone 19300101 <strong>2011</strong>12 GSK<br />

methenamine Mandelamine 19560802 201408<br />

methenamine + phenazopyridine Azo-mandelamine tabletas<br />

recubiertas entericas<br />

500mg/50mg<br />

19620628 201408<br />

methionine 20010718 201303<br />

methotrexate 19620101 201406 Sanofi Aventis<br />

Innovator products not marketed in the<br />

EEA<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 40/61

2<br />

855<br />

856<br />

857<br />

858<br />

859<br />

860<br />

861<br />

862<br />

863<br />

864<br />

865<br />

866<br />

867<br />

868<br />

869<br />

870<br />

871<br />

872<br />

873<br />

874<br />

875<br />

876<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

methoxsalen Meladinin 19580331 201303 Galderma<br />

methsuximide<br />

Celontin 19560713 201207 Pfizer<br />

Next DLP Firm's Name Comments<br />

methylbutetisalicylate 19550806 201408 Sanofi Aventis<br />

methyldigoxin 201203<br />

methyldopa 19600101 201312<br />

methyldopa + hydrochlorotiazide 19620417 201404<br />

methylene diphosphonic acid 19760901 201408 GE Healthcare<br />

methylphenobarbital 201303<br />

methylprednisolone 19571218 201310 Pfizer<br />

methylprednisolone acetate,<br />

lidocaine hydrochloride<br />

Depo Medrol + Lidocaine 19750425 201310 Pfizer<br />

methylprednisolone acetate,<br />

neomycin sulfate<br />

Neo-Medrol Acetate 19641207 201310<br />

methylsalicylate + menthol Baume Bengue 19521117 <strong>2011</strong>11 Ipsen<br />

methylsalicylate + menthol +<br />

eugenol Counterpain 19660111 201401 Pharmaswiss<br />

methylsalicylate + clove oil +<br />

capsicum oil<br />

BAUME AROMA, cream 19440313 201405 Mayoly Spindler<br />

methysergide 19480215 201202 Novartis<br />

metipamide 201305<br />

metixene 19610215 201402 Novartis<br />

metizoline 19710301 201210 Bracco<br />

metoclopramide 19740409 201204 Sanofi Aventis<br />

metoclopramide + dimeticone 19740409 201204 Sanofi Aventis<br />

metolazone 19910101 201312<br />

metopimazine 19660603 201212 Sanofi Aventis<br />

The innovator product from Pfizer is<br />

approved in DE only<br />

Innovator product from BMS has been<br />

sold to Pharmaswiss<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 41/61

2<br />

877<br />

878<br />

879<br />

880<br />

881<br />

882<br />

883<br />

884<br />

885<br />

886<br />

887<br />

888<br />

889<br />

890<br />

891<br />

892<br />

893<br />

894<br />

895<br />

896<br />

897<br />

898<br />

899<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

metoprolol 19750228 201202 AstraZeneca<br />

metoxybutropate 19850417 201210 Acraf<br />

metronidazole (excl topical use) 19590729 201207 Sanofi Aventis<br />

metronidazole + minocycline +<br />

nystatine<br />

19810601 <strong>2011</strong>11<br />

metronidazole + spiramycin Rodogyl (tablets) 19590729 201207 Sanofi Aventis<br />

metyrapone 19610614 201201 Novartis<br />

mexiletine<br />

19751006 <strong>2011</strong>10 Boehringer Ingelheim<br />

mezlocillin 19840801 201208 Bayer Schering<br />

mianserin 19740101 201312 Organon<br />

miconazole 19710731 201308 J&J<br />

miconazole combinations<br />

microcrystalline hydroxyapatite<br />

Daktozin/ Acnidazil/ Daktacort 19710731 201308 J&J<br />

Ossopan 19840319 201403 Sanofi Aventis<br />

mineral oil + isopropyl myristate Diprobath / Nujol 19770316 201208 Merck & Co.<br />

minerals and combinations (excl.<br />

with vitamins)<br />

201307<br />

minocycline 19610807 201208<br />

mitomycin 19621005 <strong>2011</strong>10 Kyowa Hakko<br />

mitoxantrone 19810615 201306<br />

mofebutazone 201402<br />

molsidomin 19770906 201209 Sanofi Aventis<br />

monmectite 19790719 201307 Ipsen<br />

morphine 19690414 201210 Merck Serono<br />

mycobacterium Bovis 19650422 201204 Pfizer<br />

nadolol 19760722 201207 BMS<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 42/61

2<br />

900<br />

901<br />

902<br />

903<br />

904<br />

905<br />

906<br />

907<br />

908<br />

909<br />

910<br />

911<br />

912<br />

913<br />

914<br />

915<br />

916<br />

917<br />

918<br />

919<br />

920<br />

921<br />

922<br />

923<br />

924<br />

925<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

nafcillin 201306<br />

Next DLP Firm's Name Comments<br />

naftazone 19871218 201312 Sanofi Aventis<br />

naftidrofuryl 19701030 201204 Merck Serono<br />

naftifine 201308<br />

nalbuphine 19790515 201305<br />

nalidixic acid 19610101 201401 Sanofi Aventis<br />

naloxone 19750414 201304 BMS<br />

naloxone combination 201304<br />

nandrolone 19600101 201312 Organon<br />

naphazoline 19461016 201207 Novartis<br />

naphazoline + tetracaine 19840802 201207 Alcon<br />

naphazoline combination Optrex Range 19780411 201207 Reckitt Benckiser<br />

naproxen 19610804 201408<br />

naproxen combination 201408<br />

nefazodone 201309<br />

neomycin 19540624 <strong>2011</strong>12 Sanofi Aventis<br />

neomycin + hydrocortisone Neo-Cortef 201408<br />

neostigmine<br />

19320701 201303<br />

Valeant Phamaceuticals<br />

Ltd<br />

nesitiride 201208 J&J<br />

netilmicin 19820101 201205 Merck & Co.<br />

niclosamide 19640323 201209 Sanofi Aventis<br />

nicotine 201408<br />

nicotinic acid 19970728 201307 Abbott<br />

niflumic acid (morniflumate) 19600101 201301 BMS<br />

nifuratel 19650504 201302<br />

nifuratel + nystatin many brand names 19761012 201303<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 43/61

2<br />

926<br />

927<br />

928<br />

929<br />

930<br />

931<br />

932<br />

933<br />

934<br />

935<br />

936<br />

937<br />

938<br />

939<br />

940<br />

941<br />

942<br />

943<br />

944<br />

945<br />

946<br />

947<br />

948<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

nifurtoinol 19630826 201408 Zambon<br />

nimorazole 19690530 201205<br />

Next DLP Firm's Name Comments<br />

nisoldipine 19950701 201207 Bayer Schering<br />

nitrazepam<br />

19650302 201303<br />

nitrofural 201310<br />

Valeant Phamaceuticals<br />

Ltd<br />

nitrofurantoin 19530228 201302 Procter & Gamble<br />

nitroprusside 19761130 <strong>2011</strong>11 UCB<br />

nitroxoline 201311<br />

nizatidine 19850803 201208 Eli Lilly<br />

nonivamide<br />

nonoxynol-9 (in contraceptive<br />

creams)<br />

19530901 <strong>2011</strong>09 Boehringer Ingelheim<br />

201205<br />

noradrenaline 201309<br />

131 I-6-Iodo-Norcholesterol 19900621 201206<br />

norethisterone 19710429 201208 J&J / Pfizer<br />

norethisterone combinations 201405<br />

norfenefrine 19590306 201203<br />

norfloxacin<br />

19821104 201311 MSD<br />

noscapine 201402<br />

nystatin 19540813 201208 BMS<br />

obidoxime 19640129 201403 Merck Serono<br />

omega-3 fatty acids 201401<br />

omoconazole 19870923 201309 Sanofi Aventis<br />

opipramol 19611012 201210 Novartis<br />

Correction of an error on DLP published<br />

in June 2010<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 44/61

2<br />

949<br />

950<br />

951<br />

952<br />

953<br />

954<br />

955<br />

956<br />

957<br />

958<br />

959<br />

960<br />

961<br />

962<br />

963<br />

964<br />

965<br />

966<br />

967<br />

968<br />

969<br />

970<br />

971<br />

972<br />

973<br />

A B C D E F<br />

Active substance name (INN)<br />

orciprenaline<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

ornidazole 19790619 201406<br />

orphenadrine 201208<br />

ouabain 201202<br />

Next DLP Firm's Name Comments<br />

19611101 201212 Boehringer Ingelheim<br />

oxaceprol 19771015 201210 Sanofi Aventis<br />

oxacillin 19620101 201301 BMS<br />

oxamniquine 19740905 <strong>2011</strong>09<br />

oxandrolone 201208<br />

oxaprozin 201211<br />

oxazepam 19631211 201212 Pfizer<br />

oxeladin 19670606 201406 IPSEN<br />

oxetorone 19730820 201408 Sanofi Aventis<br />

oxilofrine 201403<br />

oxolamine 19600618 201210 Acraf<br />

oxolamine + propyphenazone Uniplus 19630305 201210 Acraf<br />

oxomemazine 19640311 201202 Sanofi Aventis<br />

oxomemazine combination 201202<br />

oxprenolol 19680226 201202 Novartis<br />

oxybuprocaine 19570320 201208 Laboratoire Théa<br />

oxycodone + naloxone Targin 201304 Mundipharma<br />

oxymetazoline combinations 201308<br />

oxymetazoline 19620531 201308 Merck Serono<br />

oxytetracycline 19500531 201305<br />

oxytetracycline combinations 201305<br />

oxytocin 19550602 201406 Novartis<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 45/61

2<br />

974<br />

975<br />

976<br />

977<br />

978<br />

979<br />

980<br />

981<br />

982<br />

983<br />

984<br />

985<br />

986<br />

987<br />

988<br />

989<br />

990<br />

991<br />

992<br />

993<br />

A B C D E F<br />

Active substance name (INN)<br />

oxitropium<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

pancreas powder 201405<br />

Next DLP Firm's Name Comments<br />

19820504 201310 Boehringer Ingelheim<br />

pancreatic extracts 19880622 201405 Mayoly Spindler<br />

pancreatin 19800414 201405 Abbott<br />

pancreatin combination 19630313 201405 Sanofi Aventis<br />

pancrelipase 19691031 <strong>2011</strong>10 J&J<br />

pancuronium 19910101 201312 Organon<br />

panthenol 201303<br />

pantoprazole + amoxicilline +<br />

clarithromycine<br />

ZacPac 19940823 201208 Nycomed<br />

papaverine 201309<br />

papaverine + combinations 201309<br />

papaverine + homatropine +<br />

dehydrocholic acid<br />

Bilagit / Neo-bilagit /<br />

Papaverine Houde<br />

19330331 201309 Sanofi Aventis<br />

paracetamol 201205<br />

paracetamol combinations (except<br />

with acetyl salicylic acid or<br />

dexbrompheniramine or<br />

dihydrocodeine)<br />

201205<br />

paracetamol combinations with<br />

acetyl salicylic acid<br />

201302<br />

paraffin 20041228 201310 UCB<br />

paraffin combinations<br />

201310<br />

parahydroxybenzoate of benzyle 19440818 201209 Mayoly Spindler<br />

parahydroxybenzoate of benzyle<br />

combinations<br />

201209<br />

parethoxycaine 19730903 201209 Sanofi Aventis<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 46/61

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

2<br />

994 paromomycin 19601129 201211 Pfizer<br />

995 patent Blue V sodium 19740331 201304 Gerbet<br />

996 pemoline 201403<br />

997 penamecillin 201211<br />

998 penicillamine 19630404 201204<br />

999 pentaerithrityl tetranitrate 201212<br />

1000 pentazocine<br />

pentazocine combinations (except<br />

19660915 201209 Sanofi Aventis<br />

those with paracetamol)<br />

1001<br />

201209<br />

1002 pentosane 19610613 201307 Sanofi Aventis<br />

pentosane polyester +<br />

1003 phenylephrine<br />

201306<br />

1004 pentoxifylline 19670514 201205 Sanofi Aventis<br />

1005 pentoxyverine 19541215 201312 UCB<br />

1006 periciazine + propericiazine<br />

1007 perindopril<br />

19630509<br />

19880622<br />

201205<br />

201310<br />

Sanofi Aventis<br />

Servier<br />

1008 permethrine 201207<br />

permethrine + butoxyde of<br />

1009 piperonyle<br />

Charlieu anti-lice shampoo 19920108 201207 Mayoly Spindler<br />

1010 perphenazine 19521015 201302 Merck & Co.<br />

1011 pethidine 19410328 201303 Sanofi Aventis<br />

petrolatum, mineral oil<br />

(ophthalmic)<br />

1012<br />

19710101 201305 Allergan<br />

1013 phenazone <strong>2011</strong>09<br />

1014 phenazone + tetracaine 201206<br />

1015 phendimetrazine 201303<br />

1016 phenelzine 19620301 201205 Pfizer<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 47/61

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

2<br />

1017 pheniramine 201305<br />

1018 phenobarbital 19430127 201201 Sanofi Aventis<br />

1019 phenol 19870320 201304 UCB<br />

1020 phenolphtalein <strong>2011</strong>09<br />

1021 phenoxymethylpenicillin 19560601 201210 Sanofi Aventis<br />

1022 phenprocoumon 19550216 201401 Meda<br />

1023 phentermine 201306<br />

1024 phentolamine 19510402 201404 Novartis<br />

1025 phenyl(2-hydroxybenzoate) 201403<br />

1026 phenylbutazone 19520219 201302 Novartis<br />

1027 phenylephrine 19400101 201201 Sanofi Aventis<br />

1028 phenylsalicylate 201308<br />

1029 phenytoin 19600812 201201 Pfizer<br />

phenytoin sodium +<br />

1030 metylphenobarbital<br />

Dintoinale 19500420 201201 Recordati S.p.A.<br />

1031 phloroglucinol 19920218 201209 Cephalon<br />

1032 pholcodine 19580529 201205 Sanofi Aventis<br />

1033 phosphate (<br />

1034<br />

1035<br />

1036<br />

1037<br />

1038<br />

1039<br />

1040<br />

32 P) sodium 19970228 201402<br />

phytosterol 201308<br />

picloxydine 19620413 <strong>2011</strong>10 Laboratoire Théa<br />

picosulfate sodium<br />

19671001 201312 Boehringer Ingelheim<br />

pidolate calcium 201210<br />

pidolate calcium + calcium<br />

carbonate<br />

Efical/Pidocal 19911029 201210 Sanofi Aventis<br />

pidotimod 201310<br />

pilocarpine (ophthalmic) 19640101 201408 Allergan<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 48/61

2<br />

A B C D E F<br />

Active substance name (INN)<br />

pilocarpine + timolol<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Fotil/Fotil SDU 19890213 201302<br />

Next DLP Firm's Name Comments<br />

1041<br />

1042 pimethixene 19720518 <strong>2011</strong>12 Novartis<br />

1043 pimozide 19710215 201302 J&J<br />

1044 pinaverium bromide 19751201 201311 Abbott<br />

1045 pindolol 19691110 201311 Novartis<br />

1046 pipamperone 19651014 201310 J&J<br />

1047 pipecuronium 19820501 201212 Gedeon Richter<br />

1048 pipemidic acid 19741209 <strong>2011</strong>12 Sanofi Aventis<br />

1049 piperacillin 19800507 201211<br />

1050 piperazine 201402<br />

1051 pipobroman 19660701 201406 Abbott<br />

1052 pipotiazine 19720321 201303 Sanofi Aventis<br />

1053 pirenzepine 19790213 201303 Boehringer Ingelheim<br />

1054 piritramide 19690331 201403 J&J<br />

1055 pitofenone 201401<br />

1056 pivampicillin 19741031 <strong>2011</strong>10 LEO Pharma<br />

1057 pivmecillinam 19770531 201308 LEO Pharma<br />

1058 pizotifen 19690714 201307 Novartis<br />

poly (styrol, divinylbenzol)<br />

1059 sulfonic acid<br />

201404<br />

1060 polycarbophil 19920213 201402 Sanofi Aventis<br />

1061 polyestradiol combination 19590317 201403<br />

1062 polymyxin B 19560101 201201 GSK<br />

polymyxin B combinations<br />

1063<br />

Many combinations and brand<br />

names<br />

201201<br />

1064 polystyrene sulfonate 19551026 <strong>2011</strong>10 Sanofi Aventis<br />

The innovator product from MSD was<br />

withdrawn worldwide and has not been<br />

marketed in the EU since 2000<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 49/61

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

2<br />

1065 polythiazide 19611002 <strong>2011</strong>10<br />

1066 polythiazide + reserpine Renese-R 19631015 <strong>2011</strong>10<br />

1067 polyvinyl alcohol (ophthalmic) 19650827 201204 Allergan<br />

polyvinyl alcohol + povidone<br />

1068<br />

Tears Plus, Refresh, Refresh<br />

Plus, Refresh UD<br />

19810101 201204 Allergan<br />

poractant alfa<br />

1069<br />

19920806 201208 Chiesi Farmaceutici<br />

1070 porfimer sodium 19930419 201404 Axcan Pharma<br />

potassium bicarbonate + sodium<br />

1071 alginate<br />

Gaviscon Advance 201301<br />

potassium bicarbonate + sodium<br />

1072 bicarbonate<br />

19961031 201301 Reckitt Benckiser<br />

1073 potassium chloride 19600601 201404<br />

potassium chloride + sodium<br />

1074 fluoride<br />

201201<br />

potassium chloride + sodium<br />

1075 fluoride + triclosan<br />

201201<br />

1076 potassium citrate 19710106 201201 Abbott<br />

potassium iodide + sodium iodide<br />

1077<br />

Vitreolent 19600701 201207 Novartis<br />

1078 povidone iodine 19551207 201310 Mundipharma<br />

1079 poyestradiol 201403<br />

1080 prajmalium 19721222 <strong>2011</strong>12<br />

1081 pralidoxime 19680702 201407 Sanofi Aventis<br />

1082 pramocaine 19651212 <strong>2011</strong>09 Abbott<br />

1083 pranoprofen 19951212 201312 Alcon<br />

1084 prasterone 201405<br />

1085 prazepam 19741218 201212 Pfizer<br />

1086 prazosin 19740524 201203 Pfizer<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 50/61

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

2<br />

1087 prednicarbate 19851002 201204 Sanofi Aventis<br />

1088 prednisolone 19560713 201306 Pfizer<br />

1089 prednisone 19550518 201305 Sanofi Aventis<br />

1090 prenoxdiazine 19650526 201401 Sanofi Aventis<br />

1091 prilocaine 19630101 <strong>2011</strong>12 AstraZeneca<br />

1092 prilocaine + adrenaline Citanest -Adrenaline 19630101 <strong>2011</strong>12 AstraZeneca<br />

1093 primidone 19530630 201206 AstraZeneca<br />

1094 pristinamycin 19610327 201303 Sanofi Aventis<br />

1095 probenecid 19600501 201304<br />

1096 procainamide 201406<br />

1097 procaine <strong>2011</strong>09<br />

1098 procarbazine 19661007 201203 Sigma-Tau<br />

1099 procaterol 19841120 201312 Recordati S.p.A.<br />

1100 prochlorperazine 19571206 201306 Sanofi Aventis<br />

1101 procyclidine 19530307 201403 GSK<br />

1102 progabide 19840419 201204 Sanofi Aventis<br />

1103 progesterone 19710909 201312 Lab. Besins Int.<br />

1104 proglumetacine 19800201 201402 Rottapharm S.p.A.<br />

1105 proguanil 19981001 201209 AstraZeneca<br />

1106 promazine 19560413 201204<br />

1107 promegestone 19810731 201201 Sanofi Aventis<br />

1108 promethazine 19481026 201304 Sanofi Aventis<br />

1109 propantheline 19530105 201201<br />

1110 proparacaine 19710301 201403 Alcon<br />

1111 propiomazine 19600620 201406 Sanofi Aventis<br />

1112 propranolol 19650630 201406 AstraZeneca<br />

1113 propylthiouracil 201407<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 51/61

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

2<br />

1114 proscillaridin 19631028 <strong>2011</strong>10<br />

1115 protamine 19511231 201301 LEO Pharma<br />

1116 prothipendyl 201406<br />

1117 protirelin 19740101 201401 Sanofi Aventis<br />

1118 pseudoephedrine <strong>2011</strong>10<br />

1119 pseudoephedrine + tripolidine <strong>2011</strong>10<br />

1120 pyrantel 19701220 201212 Pfizer<br />

1121 pyrazinamide 19560125 201302 Bracco<br />

pyridostigmine<br />

1122<br />

19531201 201211<br />

Valeant Phamaceuticals<br />

Ltd<br />

1123 pyrimethamine 19520101 201208 Sanofi Aventis<br />

1124 pyritinol 19600117 201212 Merck Serono<br />

1125 pyrrolidone carboxylate sodium 201401<br />

1126 pyrvinium 201308<br />

1127 quinfamide 201403<br />

1128 quinidine 201301<br />

1129 quinine <strong>2011</strong>11 Sanofi Aventis<br />

1130 quinine combinations a.o. Quiniman <strong>2011</strong>11 Sanofi Aventis<br />

1131 ranitidine bismuth citrate 19950714 201206 GSK<br />

1132 reserpine 201212<br />

1133 resorcinol 201202<br />

resorcinol + sulphur<br />

1134<br />

Clearasil Sulphur and<br />

Resorcinol<br />

19850101 201211 Reckitt Benckiser<br />

1135 rifabutin 19921019 201210 Pfizer<br />

1136 rifampicin 19680501 201305 Sanofi Aventis<br />

1137 rifamycin 19620401 201403 Sanofi Aventis<br />

1138 rilmenidine 19870423 201208 Servier<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 52/61

1161<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

2<br />

1139 rimexolone 20041227 201310<br />

1140 ritodrine hydrochlorid 19720829 201208 Eumedica<br />

1141 rosoxacin 19801216 201312<br />

1142 roxatidine 19860601 201206 Sanofi Aventis<br />

1143 rutoside 19891110 201310 Abbott<br />

1144 salbutamol 19690131 201401 GSK<br />

1145 salicylamide 201402<br />

1146 salicylic acid + combinations 201209<br />

1147 salicylic acid and salts 19550315 201203<br />

1148 secnidzole 19730605 201303 Sanofi Aventis<br />

1149 selenite sodium 201407<br />

1150 selenium disulphide 201402<br />

1151 serrapeptase 19680930 <strong>2011</strong>09 Takeda<br />

1152 sertaconazole 19920310 201207 Ferrer Group<br />

1153 silver nitrate 201403<br />

1154 silver protein 19621002 201311 Mayoly Spindler<br />

1155 silver protein acetyltannate 201311<br />

1156 silver sulfadiazine 19730125 201309 Sinclair<br />

silver sulfadiazine + cerous nitrate<br />

1157<br />

Flammacerium 19730125 201309 Sinclair<br />

1158 simeticone 19670428 201404 Pfizer<br />

sodium aurothiomalate (see<br />

aurothiomalate)<br />

1159<br />

201307<br />

sodium bicarbonate<br />

1160<br />

19770908 201205 UCB<br />

sodium bicarbonate + sodium<br />

citrate + sodium fluoride<br />

201201<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 53/61

1164<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

2<br />

sodium bicarbonate + sodium<br />

sulphate + sodium hydrogen<br />

phoshate<br />

1162<br />

Normogastryl 19660111 201401 BMS<br />

1163 sodium chloride (eye drops) 201408<br />

sodium chloride, potassium<br />

chloride, calcium chloride<br />

dihydrate (+ glucose)<br />

Ringer/Ringer in Glucose<br />

(including irrigation)<br />

19710322 201403 Baxter<br />

Next DLP Firm's Name Comments<br />

1165 sodium chromate (<br />

1166<br />

1167<br />

1168<br />

1169<br />

1170<br />

1171<br />

1172<br />

1173<br />

1174<br />

1175<br />

1176<br />

1177<br />

1178<br />

1179<br />

1180<br />

1181<br />

1182<br />

1183<br />

1184<br />

51 Cr) 19971231 <strong>2011</strong>12 GE Healthcare<br />

sodium citrate 19860301 201402 Abbott<br />

somatostatin 19891203 201206 Sanofi Aventis<br />

sotalol 19730822 201408 BMS<br />

(iso) spaglumate 19830200 201405 Thea<br />

spartocine 19621001 201309<br />

spectinomycin 19700821 201201 Pfizer<br />

spiramycin 19550208 201202 Sanofi Aventis<br />

spironolactone 19620301 201211 Pfizer<br />

spironolactone + atizide Aldactazine 19640121 201211 Pfizer<br />

spironolactone + butizide Aldozone 19680308 201211<br />

spironolactone +<br />

hydrochlorothiazide<br />

Aldactazide 19601110 201211<br />

stannous fluoride 19760731 201207 GE Healthcare<br />

stannous fluoride + medronate 19820201 201301 Ge Healthcare<br />

stibogluconate 19660330 201303 GSK<br />

streptodornase 201202<br />

streptodornase + streptokinase Varidase 19330301 201202<br />

streptokinase 201202<br />

streptomycin 19560415 201304<br />

streptozocin 19820507 201205<br />

<strong>PSUR</strong> with DLP Jan 2014 will be the last<br />

<strong>PSUR</strong> BMS will submit for this product<br />

combination<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 54/61

2<br />

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

1185 strontium (<br />

1186<br />

1187<br />

1188<br />

1189<br />

1190<br />

1191<br />

1192<br />

1193<br />

1194<br />

1195<br />

1196<br />

1197<br />

1198<br />

1199<br />

1200<br />

1201<br />

1202<br />

1203<br />

1204<br />

1205<br />

1206<br />

1207<br />

1208<br />

1209<br />

89 Sr) chloride 201208<br />

sucralfate 19680223 201207 Merck Serono<br />

sulbutiamine 19960828 201202 Servier<br />

sulconazole 19870930 201209 Sanofi Aventis<br />

sulfabenzamide + sulfacetamide +<br />

sulfathiazole<br />

Sultrin 19450912 <strong>2011</strong>09<br />

sulfacetamide 201207<br />

sulfadiazine 201407<br />

sulfafurazole 201408<br />

sulfaguanidine 19740107 201301 Sanofi Aventis<br />

sulfamethopyrazine,<br />

pyrimethamine<br />

Metakelfin 19720722 201207 Pfizer<br />

sulfamethoxazole 201408<br />

sulfasalazine 19420425 201404 Pfizer<br />

sulfinpyrazone<br />

19580925 <strong>2011</strong>09<br />

sulfisoxazole 201408<br />

sulindac 19750630 201406<br />

sulphur 19850101 201211 Reckitt Benckiser<br />

sulphur + triclosan 201211<br />

sulpiride 19730110 201201 Sanofi Aventis<br />

sultopride 19861001 <strong>2011</strong>10<br />

suxamethonium 19520814 201408 GSK<br />

tacalcitol 201407<br />

talinolol 201310<br />

tamoxifen 19740429 201204 AstraZeneca<br />

tazarotene 19960312 <strong>2011</strong>12 Allergan<br />

technetium (99mTc) DMSA 201205<br />

The innovator product from Novartis is<br />

globally deregistered<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 55/61

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

2<br />

1210 technetium (99mTc) oxidronate 19830321 201303 Covidien<br />

1211 technetium (99mTc) pentetate 19900621 201211 GE Healthcare<br />

technetium (Tc-99m)<br />

1212 pyrophosphate<br />

19910204 201402 Covidien<br />

technetium(99mTc) sestamibi<br />

1213<br />

19871209 201212 Lantheus MI<br />

1214<br />

technetium (Tc-99m) tiatide 19890525 201405 Covidien<br />

1215<br />

tegafur <strong>2011</strong>12 JCS Grindeks<br />

1216 temazepam 19691126 <strong>2011</strong>11 Pfizer<br />

1217 temocillin 19841025 <strong>2011</strong>10 Eumedica<br />

1218 teniposide 19760405 201304 BMS<br />

1219 tenoate sodium 19640515 201205 Sanofi Aventis<br />

tenoate sodium + eucalyptus +<br />

1220 paracetamol<br />

TROPHIRES 19640515 201205 Sanofi Aventis<br />

1221 terazosin 19841130 201211 Abbott<br />

1222 terbutaline 19701231 <strong>2011</strong>12 AstraZeneca<br />

1223 terconazole 201212 J&J<br />

1224 terfenadine <strong>2011</strong>12<br />

1225 terguride maleate 201311<br />

1226 tertatolol<br />

testosterone (implants)<br />

19860425 <strong>2011</strong>10 Servier<br />

19780701 201309 Organon<br />

1227<br />

testosterone propionate,<br />

testosterone phenyl propionate<br />

and testosterone iso hexanoate<br />

and testosterone decanoate<br />

1228<br />

Sustanon 19650930 201309 Organon<br />

1229 tetracaine 19730601 201206 Novartis<br />

Substance moved from <strong>PSUR</strong> WS list<br />

as not authorised any longer in EE<br />

(former P-RMS)<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 56/61

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

2<br />

1230 tetracosactide 19650507 201405 Novartis<br />

1231 tetracycline 19531119 201211<br />

1232 tetrazepam 19670503 201205 Sanofi Aventis<br />

1233 tetryzoline 201406<br />

1234 theophylline 19600630 201206<br />

1235 thiethylperazine 19601222 <strong>2011</strong>12 Novartis<br />

1236 thiocolchicoside 19560704 201303 Sanofi Aventis<br />

1237 thioguanine 19660118 201201 GSK<br />

1238 thiopental 201403<br />

1239 thioperazine 19591214 201212 Sanofi Aventis<br />

thioridazine<br />

1240<br />

19590201 201302<br />

thiotepa<br />

1241<br />

19590309 201203 Adienne<br />

1242 thiothixene 19670724 201207<br />

1243 thrombin 19430316 201203<br />

thymol, levomenthol, salol<br />

1244<br />

Borostyrol, Nisacalm 19430406 201404 Mayoly Spindler<br />

1245 thyroglobulin 19430831 201408<br />

1246 thyrotricine (or tyrothricin) 201408<br />

thyrotropine releasing hormone<br />

(synthetic)<br />

1247<br />

19790501 201302<br />

1248 thyroxine 19520101 201312 GSK<br />

1249 thyroxine combinations Novothyral 19680527 201212 Merck Serono<br />

1250 tiaprofenic acid 19740826 201408 Sanofi Aventis<br />

1251 tibenzonium iodide 19761123 201312 Recordati S.p.A.<br />

1252 ticarcillin 19730912 201309 GSK<br />

1253 ticarcillin + clavulanate Timentin 19730912 201309 GSK<br />

Innovator product by Novartis<br />

deregistered<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 57/61

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

2<br />

1254 tilactase 201211<br />

1255 tilidine 19700708 201304<br />

1256 tiliquinol + tilbroquinol Intetrix 19651115 201211 IPSEN<br />

1257 tinidazole 19720615 201206 Pfizer<br />

tinidazole + nystatin<br />

1258<br />

Fasigyn N Ovulos 19781120 201206 Pfizer<br />

1259 tinidazole + tioconazole Fasigyn Vt 19751008 201206<br />

1260 tinzaparine 19910228 201302 LEO Pharma<br />

1261 tiropramide 19820330 201312 Rottapharm S.p.A.<br />

1262 tiopronine 19770901 201208 Sanofi Aventis<br />

1263 tobramycin 19731029 <strong>2011</strong>10 Eli Lilly<br />

tobramycin (ophtalmic and otic<br />

1264 use)<br />

19880516 201403 Allergan<br />

1265 tolazamide 201408<br />

1266 tolbutamide 201407<br />

1267 tolfenamic acid 201208<br />

1268 tolmetin 201201<br />

1269 tolnaftate 19771016 201210 Sanofi Aventis<br />

1270 tolnaftate + triclosan 201210<br />

1271 tolnaftate + nystatine 201210<br />

1272 tolperisone 201211<br />

1273 torasemide 19870414 201211 Meda<br />

1274 tosylchloramide 201303 Bracco<br />

1275 tramadol 19730418 201405 Grünenthal<br />

tramazoline<br />

1276<br />

19640201 201312 Boehringer Ingelheim<br />

1277 tranexamic acid 19660121 201301 Pfizer<br />

1278 tretinoin 19730125 201201<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 58/61

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

2<br />

1279 tretinoin + tocopherol Atrederm 201408 Pliva<br />

1280 triamcinolone acetonide 19531214 201207 BMS<br />

1281 triamcinolone combinations 201207<br />

1282 triamterene 201206<br />

1283 tribenoside 19670406 201204 Novartis<br />

tribenoside + lidocaine<br />

1284<br />

201401 Novartis<br />

1285 triclabendazole 19971028 201210 Novartis<br />

1286<br />

tricoflos 20010718 201308<br />

1287 triclorcarban <strong>2011</strong>09<br />

1288 triclosan 19850101 201211 Reckitt Benckiser<br />

1289 tridecanamine undecylenate 201301<br />

1290 triethanolamine salicylate 201301<br />

1291 trifluoperazine 19861001 201310 Sanofi Aventis<br />

trifluperidol<br />

1292<br />

19640131 201201<br />

1293 trifluridine 201303<br />

1294 triflusal 201408<br />

1295 trihexyphenidyl 19560605 201312 Sanofi Aventis<br />

1296 trimebutine 19880315 201205 Pfizer<br />

1297 trimebutine + ruscogenin Proctolog 19731210 201205 Pfizer<br />

1298 trimecaine 201405<br />

1299 trimepiridine 201202<br />

1300 trimetazidine 20010806 201202 Servier<br />

1301 trimethoprim 201206<br />

1302 trimipramine 19601005 <strong>2011</strong>10 Sanofi Aventis<br />

1303 tropatepine 19730327 201407 Sanofi Aventis<br />

1304 tropicamide 19510301 201403 Alcon<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 59/61

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

2<br />

1305 trospium 19841017 <strong>2011</strong>09 Montavit<br />

troxerutine<br />

1306<br />

201406 Novartis<br />

undecylenic acid + zinc<br />

1307 undecylenate<br />

201305<br />

unoprostone<br />

1308<br />

19941012 201209 Novartis<br />

urapidil<br />

1309<br />

19800731 201207 Nycomed<br />

1310 urea 201304<br />

urea (<br />

1311<br />

1312<br />

1313<br />

1314<br />

1315<br />

1316<br />

1317<br />

1318<br />

1319<br />

1320<br />

1321<br />

1322<br />

1323<br />

1324<br />

1325<br />

1326<br />

1327<br />

13 C) HELI-KIT 75 mg, powder for<br />

drinkable solution<br />

19970500 201302 Mayoly Spindler<br />

urokinase 201312<br />

valproic acide (incl. salts) 19670123 201201 Sanofi Aventis<br />

valpromide 19730723 201307 Sanofi Aventis<br />

vancomycin 19550101 201201 Eli Lilly<br />

vasopressin 201306<br />

verapamil 19630125 201301 Abbott<br />

viminol 19710301 201408 Zambon<br />

vinblastine <strong>2011</strong>10<br />

vincamine 19820626 201406 Sanofi Aventis<br />

vincristine 19950412 201303<br />

vindesine 19790411 201204 Eli Lilly<br />

vinpocetin<br />

vitamins and vitamin<br />

201407<br />

combinations including<br />

dexpanthenol and minerals<br />

201210<br />

warfarin 19620531 201205 Abbott<br />

xipamide 19690730 201407 Eli Lilly<br />

xylometazoline 19880513 201405 Novartis<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 60/61

A B C D E F<br />

Active substance name (INN)<br />

Innovator brand name (for<br />

fixed combination products<br />

only)<br />

Proposed EU<br />

harmonised birth<br />

date<br />

Next DLP Firm's Name Comments<br />

2<br />

1328 yohimbine 19440601 201205 Sanofi Aventis<br />

1329 zinc salts 201407<br />

1330 zolpidem 19870609 201306 Sanofi Aventis<br />

1331 zopiclone 19841210 201205 Sanofi Aventis<br />

1332 zuclopenthixol 19760531 201305 Lundbeck<br />

<strong>PSUR</strong> <strong>Synchronisation</strong> <strong>List</strong> - Status <strong>December</strong> <strong>2011</strong> page 61/61

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