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PRODUCT DETAIL

Teriflunomide G.L. Pharma 14 mg filmom obalené tablety

Code 3642E
MA number 59/0124/23-S
Product Form: tbl flm 14x14 mg (blis.OPA/Al/PVC/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AK Dihydroorotate dehydrogenase (DHODH) inhibitors
L04AK02 Teriflunomide
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: 30.05.2023
Validity: 30.05.2028
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL_Teriflunomide G.L. Pharma 14 mg filmom obalené tablety_11.2023.pdf  
SPC: SPC_Teriflunomide G.L. Pharma 14 mg filmom obalené tablety_03.2024.pdf  
Safety feature Yes
Data update: 21.03.2024
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