Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Volibris 2.5 mg film-coated tablets.
Volibris 5 mg film-coated tablets.
Volibris 10 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet (tablet). Volibris 2.5 mg film-coated tablets: White, 7 mm round, convex, film-coated tablet with "GS" debossed on one side and "K11" on the other side. Volibris 5 mg film-coated tablets: Pale-pink, 6.6 mm square, convex, film-coated tablet with "GS" debossed on one side and "K2C" on the other side. Volibris 10 mg film-coated tablets: Deep-pink, 9.8 mm × 4.9 mm oval, convex, film-coated tablet with "GS" debossed on one side and "KE3" on the other side. |
Each tablet contains 2.5 mg of ambrisentan.
Excipient(s) with known effect:
Each tablet contains approximately 92.6 mg of lactose (as monohydrate) and approximately 0.25 mg of lecithin (soya) (E322).
Each tablet contains 5 mg of ambrisentan.
Excipient(s) with known effect:
Each tablet contains approximately 90.3 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).
Each tablet contains 10 mg of ambrisentan.
Excipient(s) with known effect:
Each tablet contains approximately 85.5 mg of lactose (as monohydrate), approximately 0.25 mg of lecithin (soya) (E322) and approximately 0.45 mg of allura red AC aluminium lake (E129).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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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 |
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Tablet core: Lactose monohydrate Film-coat: Volibris 2.5 mg film-coated tablets: Polyvinyl alcohol Volibris 5 mg and 10 mg film-coated tablets: Polyvinyl alcohol |
Volibris 2.5 mg film-coated tablets:
Opaque, white high density polyethylene (HDPE) bottles closed with polypropylene child-resistant closures with a polyethylene faced induction heat seal liner.
The bottles contain 30 film-coated tablets.
Volibris 5 mg and 10 mg film-coated tablets:
PVC/PVDC/aluminium foil blisters.
Pack sizes with unit dose blisters of 10 × 1 or 30 × 1 film-coated tablets.
Not all pack sizes may be marketed.
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Volibris 2.5 mg film-coated tablets:
EU/1/08/451/005
Volibris 5 mg film-coated tablets:
EU/1/08/451/001
EU/1/08/451/002
Volibris 10 mg film-coated tablets:
EU/1/08/451/003
EU/1/08/451/004
Date of first authorisation: 21 April 2008
Date of latest renewal: 14 January 2013
| Drug | Countries | |
|---|---|---|
| VOLIBRIS | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, South Africa |
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