Volibris (ambrisentan)
- Region
- 🇪🇺 EU
- Active substance
- ambrisentan
- Company
- GlaxoSmithKline Trading Services Limited
- Status
- Authorised
- Therapeutic area
- Hypertension, Pulmonary
- EU approval
- Mon 21 Apr 2008
- Application
- EMEA/H/C/000839
- ATC
- C02KX02
- Official record
- www.ema.europa.eu
Indication
Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. Volibris is indicated for treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ambrisentan Viatris (previously Ambrisentan Mylan) Authorised · Viatris Limited
- 🇪🇺 Ambrisentan Zentiva Application withdrawn · Zentiva k.s.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.