ESP Pharma” 10 mg film-coated tablets Montelukast sodium DK/H/17

I. INTRODUCTION
Based on the review of the quality, safety and efficacy data, the Member States have granted a
marketing authorisation for Montelukast ”Esp Pharma” 10 mg film-coated tablets, from ESP Pharma
Limited. The product was authorised in Denmark on 2 July 2010. The product is indicated for the
treatment of asthma as add-on therapy in those patients 15 years of age and older with mild to
moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom
“as-needed” short acting β-agonists provide inadequate clinical control of asthma. In those asthmatic
patients 15 years of age and older in whom Montelukast ”ESP Pharma” is indicated in asthma,
Montelukast ”ESP Pharma” can also provide symptomatic relief of seasonal allergic rhinitis.
Montelukast ”ESP Pharma” is also indicated in the prophylaxis of asthma in patients 15 years of age
and older in which the predominant component is exercise-induced bronchoconstriction.
Montelukast is used as an anti-ashmatics for systemic use. Montelukast is an orally active compound
which binds with high affinity and selectively to the CycLT1 receptor. The cycteinyl leukotrines
(LTC4, LTD4, LTE4) are potent inflammatory eicosanoids released form various cells including mast
cells and eosinophils. These important pro-ashmatic mediator bind to cycteinly leukotriene receptors
(CysLT) found in the human airway and cause airway actions, including bronchoconstriction, mucous
secretions, vascular permeability and eosinophil recruitment. Bronchodilation was observed within 2
hours of oral administration.
This decentralised procedure concerns a generic application claiming essential similarity with the
reference product Singulair 10 mg film-coated tablets which has been authorised in the RMS since
January 20, 1998.
A bioequivalence study has been preformed with Singulair 10 mg film-coated tablets, Merck Sharp &
Dohme, from the German market, as the reference product.
The marketing authorisation is granted based on article 10.1 of Directive 2001/83/EC.
II. QUALITY ASPECTS
II.1 Introduction
Each film-coated tablet contains montelukast sodium equivalent to 10 mg of montelukast.
The tablet is a beige, square, biconvex film-coated tablet with M engraved on one side.
The product is packed in OPA-Al-PVC/Al blister packs in various pack sizes.
The excipients in the tablet core are: Cellulose, microcrystalline; hydroxypropylcellulose;
croscarmellose sodium; lactose monohydrate and magnesium stearate.
The film-coating consists of: Lactose monohydrate; hypromellose 15cP; titanium dioxide (E171);
macrogol 4000; iron oxide yellow (E172) and iron oxide red (E172).
Compliance with Good Manufacturing Practice
The RMS has been assured that acceptable standards of GMP (see Directive 2003/94/EC) are in place
for this product type at all sites responsible for the manufacturing of the active substance as well as for
the manufacturing and assembly of this product prior to granting its national authorisation.
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