PSUR Synchronisation List - December 2011
PSUR Synchronisation List - December 2011
PSUR Synchronisation List - December 2011
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
1<br />
2<br />
3<br />
4<br />
5<br />
6<br />
7<br />
8<br />
9<br />
10<br />
11<br />
12<br />
13<br />
14<br />
15<br />
16<br />
17<br />
18<br />
19<br />
20<br />
21<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 />
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
2<br />
22<br />
23<br />
24<br />
25<br />
26<br />
27<br />
28<br />
29<br />
30<br />
31<br />
32<br />
33<br />
34<br />
35<br />
36<br />
37<br />
38<br />
39<br />
40<br />
41<br />
42<br />
43<br />
44<br />
45<br />
46<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 />
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
2<br />
47<br />
48<br />
49<br />
50<br />
51<br />
52<br />
53<br />
54<br />
55<br />
56<br />
57<br />
58<br />
59<br />
60<br />
61<br />
62<br />
63<br />
64<br />
65<br />
66<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 />
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
2<br />
67<br />
68<br />
69<br />
70<br />
71<br />
72<br />
73<br />
74<br />
75<br />
76<br />
77<br />
78<br />
79<br />
80<br />
81<br />
82<br />
83<br />
84<br />
85<br />
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
2<br />
89<br />
90<br />
91<br />
92<br />
93<br />
94<br />
95<br />
96<br />
97<br />
98<br />
99<br />
100<br />
101<br />
102<br />
103<br />
104<br />
105<br />
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 />
2<br />
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
140<br />
141<br />
142<br />
143<br />
144<br />
145<br />
146<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 />
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
2<br />
147<br />
148<br />
149<br />
150<br />
151<br />
152<br />
153<br />
154<br />
155<br />
156<br />
157<br />
158<br />
159<br />
160<br />
161<br />
162<br />
163<br />
164<br />
165<br />
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
2<br />
167<br />
168<br />
169<br />
170<br />
171<br />
172<br />
173<br />
174<br />
175<br />
176<br />
177<br />
178<br />
179<br />
180<br />
181<br />
182<br />
183<br />
184<br />
185<br />
186<br />
187<br />
188<br />
189<br />
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
2<br />
191<br />
192<br />
193<br />
194<br />
195<br />
196<br />
197<br />
198<br />
199<br />
200<br />
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
2<br />
211<br />
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
2<br />
234<br />
235<br />
236<br />
237<br />
238<br />
239<br />
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