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VOLIBRIS Film-coated tablet (2018)

Active ingredients: Ambrisentan

Product Name and Form

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.

Qualitative and Quantitative Composition

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.

Chemical substance
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
Microcrystalline cellulose
Croscarmellose sodium
Magnesium stearate

Film coat:

Polyvinyl alcohol (partially hydrolysed)
Talc (E553b)
Titanium dioxide (E171)
Macrogol 3350
Lecithin (soya) (E322)
Allura red AC Aluminium Lake (E129)

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Date of first authorisation: 21 April 2008
Date of latest renewal: 24 April 2013

Marketing authorization number:

EU/1/08/451/001
EU/1/08/451/002