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: |
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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 |