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.

Ambrisentan Mylan can only be obtained with a prescription and treatment must be started by a doctor who has experience in the treatment of PAH.

Ambrisentan Mylan is available as tablets (5 and 10 mg). Treatment is started at a dose of 5 mg daily and the doctor may increase it to 10 mg daily depending on response and any side effects experienced by the patient. The dose is increased to 10 mg daily when the medicine is used with tadalafil (another medicine for PAH). When taken with ciclosporin (a medicine that reduces the activity of the immune system) the dose of Ambrisentan Mylan should be 5 mg daily and the patient should be closely monitored by their doctor.

For more information about using Ambrisentan Mylan, see the package leaflet or contact your doctor or pharmacist.

PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs. It causes high blood pressure in the vessels taking blood from the heart to the lungs and reduces the flow of blood to the lungs. As a result, the amount of oxygen that can get into the blood in the lungs is reduced, making physical activity more difficult. The active substance in Ambrisentan Mylan, ambrisentan, blocks the receptors (targets) for a hormone called endothelin, which causes blood vessels to become narrow. By blocking the effect of endothelin, Ambrisentan Mylan prevents the vessels becoming too narrow helping to lower the blood pressure and improving symptoms.

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Volibris, and do not need to be repeated for Ambrisentan Mylan.

As for every medicine, the company provided studies on the quality of Ambrisentan Mylan. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
 

Because Ambrisentan Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The European Medicines Agency concluded that, in accordance with EU requirements, Ambrisentan Mylan has been shown to have comparable quality and to be bioequivalent to Volibris. Therefore, the Agency’s view was that, as for Volibris, the benefit of Ambrisentan Mylan outweighs the identified risk and it can be authorised for use in the EU.

The company that markets Ambrisentan Mylan will provide a patient card containing important information on the medicine’s side effects and the need to avoid pregnancy during treatment.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ambrisentan Mylan have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Ambrisentan Mylan are continuously monitored. Side effects reported with Ambrisentan Mylan are carefully evaluated and any necessary action taken to protect patients.

Ambrisentan Mylan : EPAR - Medicine overview

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Ambrisentan Mylan : EPAR - Risk-management-plan summary

Product information

Ambrisentan Mylan : EPAR - Product Information

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Latest procedure affecting product information: N/0008

25/04/2023

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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).

Ambrisentan Mylan : EPAR - All authorised presentations

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Product details

Name of medicine
Ambrisentan Mylan
Active substance
ambrisentan
International non-proprietary name (INN) or common name
ambrisentan
Therapeutic area (MeSH)
Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
C02KX02

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.

Authorisation details

EMA product number
EMEA/H/C/004985

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.

Marketing authorisation holder
Mylan S.A.S

117 Allee des Parcs
69800 Saint-Priest
France

Marketing authorisation issued
20/06/2019
Revision
4

Assessment history

Ambrisentan Mylan : EPAR - Procedural steps taken and scientific information after the authorisation

Ambrisentan Mylan : EPAR - Public assessment report

CHMP summary of positive opinion for Ambrisentan Mylan

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