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PRODUCT DETAIL

ZEPATIER 50 mg/100 mg filmom obalené tablety

Code 0666C
MA number EU/1/16/1119/001
Product Form: tbl flm 28x50 mg/100 mg (blis.Al/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 42 - CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK)
ATC:
J ANTIINFECTIVES FOR SYSTEMIC USE
J05 ANTIVIRALS FOR SYSTEMIC USE
J05A DIRECT ACTING ANTIVIRALS
J05AP ?
J05AP54 Elbasvir and grazoprevir
Shelf life: 36
Container: blister Al/Al
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: 22.07.2016
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 12.05.2021
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