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PRODUCT DETAIL

Pirfenidone Zentiva

Code 2021E
MA number 59/0246/22-S
Product Form: tbl flm 252x267 mg (blis.PVC/PCTFE/Al-perfor.)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AX Other immunosuppressants
L04AX05 Pirfenidone
Shelf life: 30
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 19.09.2022
Validity: 19.09.2027
PIL: PIL_Pirfenidone Zentiva_09 2022.pdf  
SPC: SPC_Pirfenidone Zentiva_09 2022.pdf  
Safety feature Yes
Data update: 21.09.2022
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