| Code | 3825E | ||||||||||
| MA number | 59/0159/23-S | ||||||||||
| Product Form: | tbl flm 84x14 mg (blis.Al/PVC/Al/OPA) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Bausch Health Ireland Limited , Ireland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| 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: | 14.07.2023 |
| Validity: | 14.07.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| Dokument: |
Teriflunomid_Karta pre pacienta.pdf
|
| SPC: |
SPC_Clefirem_10.2024.pdf
|
| PIL: |
PIL_Clefirem_10.2024.pdf
|
| Dokument: |
Teriflunomid_Pokyny pre zdravotníckych pracovníkov.pdf
|
| Safety feature | Yes |
| Data update: | 10.10.2024 |
