| Code | 5320E | ||||||||||
| MA number | 59/0013/24-S | ||||||||||
| Product Form: | tbl flm 84x1x801 mg (blis.PVC/PE/PCTFE/Al-jednotl.dávka) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Accord Healthcare Polska Sp. z o.o., Poland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| 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: | 08.02.2024 |
| Validity: | 08.02.2029 |
| SPC: |
SPC_Pirfenidón Accord_07.2025.pdf
|
| PIL: |
PIL_Pirfenidón Accord_07.2025.pdf
|
| Safety feature | Yes |
| Data update: | 13.02.2024 |
