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PRODUCT DETAIL

Teriflunomide Mylan 14 mg filmom obalené tablety

Code 2367E
MA number EU/1/22/1698/001
Product Form: tbl flm 28x14 mg (blis.Al/OPA/PVC/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Mylan Pharmaceuticals Limited, Ireland
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AA Selective immunosuppressants
L04AA31 Teriflunomide
Shelf life: 24
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 09.11.2022
Validity: 09.11.2027
SmPC + PL: European Medicines Agency's database
Dokument: Teriflunomid_Karta pre pacienta.pdf  
Dokument: Teriflunomid_Pokyny pre zdravotníckych pracovníkov.pdf  
Safety feature Yes
Data update: 24.11.2022
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