Ambrisentan Viatris (previously Ambrisentan Mylan) (ambrisentan)
- Region
- 🇪🇺 EU
- Active substance
- ambrisentan
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Hypertension, Pulmonary
- EU approval
- Thu 20 Jun 2019
- Designations
- Generic
- Application
- EMEA/H/C/004985
- ATC
- C02KX02
- Official record
- www.ema.europa.eu
Indication
Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Volibris Authorised · GlaxoSmithKline Trading Services Limited
- 🇪🇺 Ambrisentan Zentiva Application withdrawn · Zentiva k.s.
Follow Ambrisentan Viatris (previously Ambrisentan Mylan)
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.