| Code | 2935E | ||||||||||
| MA number | 59/0044/23-S | ||||||||||
| Product Form: | tbl flm 84x1x14 mg (blis.OPA/Al/PVC/Al-perfor.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| 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: | 23.02.2023 |
| Validity: | 23.02.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_TEREBYO 14 mg_02_2023.pdf
|
| PIL: |
PIL_TEREBYO 14 mg_02.2023.pdf
|
| Dokument: |
Teriflunomid_Karta pre pacienta.pdf
|
| Dokument: |
Teriflunomid_Pokyny pre zdravotníckych pracovníkov.pdf
|
| Safety feature | Yes |
| Data update: | 07.03.2023 |
