Ambrisentan Mylan

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ambrisentan

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 15/07/2019

Authorisation details

Product details
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
GenericGeneric

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
Marketing-authorisation holder
Mylan S.A.S
Date of issue of marketing authorisation valid throughout the European Union
20/06/2019
Contact address

117 Allee des Parcs
69800 Saint-Priest
France

Product information

20/06/2019 Ambrisentan Mylan - EMEA/H/C/004985 -

Contents

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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.

Assessment history

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