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PRODUCT DETAIL

Ambrisentan Mylan 5 mg filmom obalené tablety

Code 7300D
MA number EU/1/19/1368/005
Product Form: tbl flm 60x1x5 mg (blis.PVC/PVDC/Al - jedn.d.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 58 - HYPOTENSIVA
ATC:
C CARDIOVASCULAR SYSTEM
C02 ANTIHYPERTENSIVES
C02K OTHER ANTIHYPERTENSIVES
C02KX Antihypertensives for pulmonary arterial hypertension
C02KX02 Ambrisentan
Shelf life: 36
Container: blister PVC/PVDC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 20.06.2019
Validity: 20.06.2024
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 29.03.2021
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