| Code | 4592C | ||||||||||
| MA number | EU/1/11/667/018 | ||||||||||
| Product Form: | tbl flm 84 (4x21)x801 mg (blis.PVC/Aclar/PCTFE) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| 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: | 22.06.2017 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
Pirfenidón_Kontrolný zoznam pre lekára.pdf
|
| Safety feature | Yes |
| Data update: | 23.01.2020 |
