Code | 6870E | ||||||||||
MA number | 59/0180/24-S | ||||||||||
Product Form: | tbl flm 28x14 mg (blis.OPA/Al/PVC-Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Pharmathen S.A., Greece | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 18 | ||||||||||
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: | 19.07.2024 |
Validity: | 19.07.2029 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Teriflunomide Pharmathen 14 mg filmom obalené tablety_07 2024.pdf |
SPC: | SPC_Teriflunomide Pharmathen 14 mg filmom obalené tablety_07 2024.pdf |
Safety feature | Yes |
Data update: | 01.08.2024 |