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PRODUCT DETAIL

TEREBYO 14 mg

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:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AA Selective immunosuppressants
L04AA31 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: 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
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