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PRODUCT DETAIL

Macitentan Accord 10 mg filmom obalené tablety

Code 1334F
MA number EU/1/25/1970/004
Product Form: tbl flm 30x1x10 mg (blis.PVC/PE/PVDC - jednotk.bal.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Accord Healthcare S.L.U, Spain
Therapeutic Class: 58 - HYPOTENSIVA
ATC:
C CARDIOVASCULAR SYSTEM
C02 ANTIHYPERTENSIVES
C02K OTHER ANTIHYPERTENSIVES
C02KX Antihypertensives for pulmonary arterial hypertension
C02KX04 Macitentan
Shelf life: 24
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 24.09.2025
Validity: 24.09.2030
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 09.10.2025
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