Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Volibris 5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Pale-pink, square, convex, film-coated tablet with “GS” debossed on one side and “K2C” on the other side. |
Each tablet contains 5 mg of ambrisentan.
Excipient(s) with known effect: Each tablet contains approximately 95 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.11 mg of Allura red AC Aluminium Lake (E129).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ambrisentan |
Ambrisentan is an orally active, propanoic acid-class, ERA selective for the endothelin A (ETA) receptor. Endothelin plays a significant role in the pathophysiology of PAH. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film coat: Polyvinyl alcohol (partially hydrolysed) |
PVC/PVDC/aluminium foil blisters.
Pack sizes with unit dose blisters of 10x1 or 30x1 film-coated tablets.
Not all pack sizes may be marketed.
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
EU/1/08/451/001
EU/1/08/451/002
Date of first authorisation: 21 April 2008
Date of latest renewal: 24 April 2013
| Drug | Countries | |
|---|---|---|
| VOLIBRIS | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, South Africa |
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