Code | 3425B | ||||||||||
MA number | EU/1/13/837/003 | ||||||||||
Product Form: | cps end 168x240 mg (blis.PVC/PE/PVDC-PVC/alu) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Biogen Netherlands B.V., Netherland | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | blister PVC/PE/PVDC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 30.01.2014 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | DHCP Tecfidera_18-Nov-2015.pdf |
Dokument: | DHPC Tacfidera 4 12 2014.pdf |
Safety feature | Yes |
Data update: | 09.10.2023 |