Basic Information
Ambrisentan Mylan
Regulatory Information
EMEA/H/C/004985
June 20, 2019
7
April 11, 2024
Company Information
Ireland
Damastown Industrial Park Mulhuddart Dublin Dublin 15
VIATRIS PHARMA LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.