| Code | 2590E | ||||||||||
| MA number | 59/0316/22-S | ||||||||||
| Product Form: | tbl flm 84x14 mg (blis.Al/PVC/Al/OPA) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 30 | ||||||||||
| Container: | blister Al/PVC/Al/OPA | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 05.01.2023 |
| Validity: | 05.01.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Bozilos_12_2022.pdf
|
| PIL: |
PIL_Bozilos_12_2022.pdf
|
| Dokument: |
Teriflunomid_Karta pre pacienta.pdf
|
| Dokument: |
Teriflunomid_Pokyny pre zdravotnickych pracovnikov.pdf
|
| Safety feature | Yes |
| Data update: | 12.01.2023 |
