OPSUMIT Film-coated tablet Ref.[9322] Active ingredients: Macitentan

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B 2340, Beerse, Belgium

Product name and form

Opsumit 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

5.5 mm, round, biconvex, white to off-white film-coated tablets, debossed with “10” on both sides.

Qualitative and quantitative composition

Each film-coated tablet contains 10 mg macitentan.

Excipients with known effect: Each film-coated tablet contains approximately 37 mg of lactose (as monohydrate) and approximately 0.06 mg of soya bean lecithin (E322).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Macitentan

Macitentan is an orally active potent endothelin receptor antagonist, active on both ETA and ETB receptors. Endothelin (ET)-1 and its receptors (ETA and ETB) mediate a variety of effects such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation. In disease conditions such as PAH, the local ET system is upregulated and is involved in vascular hypertrophy and in organ damage.

List of Excipients

Tablet core:

Lactose monohydrate
Microcrystalline cellulose (E460i)
Sodium starch glycolate Type A
Povidone K-30
Magnesium stearate (E572)
Polysorbate 80 (E433)

Film coating:

Poly(vinyl-alcohol) (E1203)
Titanium dioxide (E171)
Talc (E553b)
Soya bean lecithin (E322)
Xanthan gum (E415)

Pack sizes and marketing

White, opaque PVC/PE/PVdC/Aluminium blisters in cartons containing 15 or 30 film-coated tablets.

White high-density polyethylene (HDPE) bottles with child-resistant closure and a silica gel desiccant. Cartons containing 1 bottle of 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B 2340, Beerse, Belgium

Marketing authorization dates and numbers

EU/1/13/893/001
EU/1/13/893/002
EU/1/13/893/003

Date of first authorisation: 20 December 2013
Date of latest renewal: 23 August 2018

Drugs

Drug Countries
OPSUMIT Austria, Australia, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

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