en

PRODUCT DETAIL

Opsumit 10 mg filmom obalené tablety

Code 9053A
MA number EU/1/13/893/001
Product Form: tbl flm 15x10 mg (blis.PVC/PE/PVDC/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 58 - HYPOTENSIVA
ATC:
C CARDIOVASCULAR SYSTEM
C02 ANTIHYPERTENSIVES
C02K OTHER ANTIHYPERTENSIVES
C02KX Antihypertensives for pulmonary arterial hypertension
C02KX04 Macitentan
Shelf life: 60
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 20.12.2013
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 13.09.2018
eu-flag.png sk-flag.png