Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B 2340, Beerse, Belgium
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. |
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 Film coating: Poly(vinyl-alcohol) (E1203) |
White, opaque PVC/PE/PVdC/Aluminium blisters in cartons containing 15 or 30 film-coated tablets.
Not all pack sizes may be marketed.
Janssen-Cilag International NV, Turnhoutseweg 30, B 2340, Beerse, Belgium
EU/1/13/893/001
EU/1/13/893/002
Date of first authorisation: 20 December 2013
Date of latest renewal: 23 August 2018
| Drug | Countries | |
|---|---|---|
| OPSUMIT | Austria, Australia, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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