Ambrisentan Mylan
ambrisentan
Table of contents
Overview
Ambrisentan Mylan is a medicine that is used alone or combined with other medicines to treat adults with pulmonary arterial hypertension (PAH).
PAH is abnormally high blood pressure in the arteries of the lungs. Ambrisentan Mylan is used in patients with class II or III disease. The ‘class’ reflects the severity of the disease: ‘class II’ involves slight limitation of physical activity and ‘class III’ involves marked limitation of physical activity. Ambrisentan Mylan is effective in PAH with no identified cause and in PAH caused by connective tissue disease.
Ambrisentan Mylan contains the active substance ambrisentan and is a ‘generic medicine’. This means that Ambrisentan Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Volibris.
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Ambrisentan Mylan : EPAR - Medicine overview (PDF/93.59 KB)
First published: 15/07/2019
EMA/244875/2019 -
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Ambrisentan Mylan : EPAR - Risk-management-plan summary (PDF/42.69 KB)
First published: 15/07/2019
Authorisation details
Product details | |
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Name |
Ambrisentan Mylan
|
Agency product number |
EMEA/H/C/004985
|
Active substance |
ambrisentan
|
International non-proprietary name (INN) or common name |
ambrisentan
|
Therapeutic area (MeSH) |
Hypertension, Pulmonary
|
Anatomical therapeutic chemical (ATC) code |
C02KX02
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
Mylan S.A.S
|
Revision |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
20/06/2019
|
Contact address |
117 Allee des Parcs |
Product information
25/04/2023 Ambrisentan Mylan - EMEA/H/C/004985 - N/0008
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antihypertensives
Therapeutic 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.