Code | 1297E | ||||||||||
MA number | 59/0183/22-S | ||||||||||
Product Form: | tbl flm 252(3x84)x801 mg (fľ.HDPE) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | TEVA Pharmaceuticals Slovakia s.r.o., Slovakia | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 29.06.2022 |
Validity: | 29.06.2027 |
Dokument: | Pirfenidón_Kontrolný zoznam pre lekára.pdf |
SPC: | SPC_Pirfenidone Teva 267 mg_ 801 mg tbl flm_06.2024.pdf |
PIL: | PIL_Pirfenidone Teva 267 mg_ 801 mg tbl flm_06.2024.pdf |
Safety feature | Yes |
Data update: | 01.07.2022 |