| Code | 0104F | ||||||||||
| MA number | 59/0192/25-S | ||||||||||
| Product Form: | tbl flm 98 (7x14)x14 mg (blis.OPA/Al/PVC//Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Teva B.V., Netherland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 26.05.2025 |
| Validity: | 26.05.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Teriflunomid Teva B.V. 14 mg_tbl flm_05/2025_REG.pdf
|
| PIL: |
PIL_Teriflunomid Teva B.V. 14 mg_tbl flm_05/2025_REG.pdf
|
| Safety feature | Yes |
| Data update: | 20.06.2025 |
