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PRODUCT DETAIL

Tecfidera 120 mg tvrdé gastrorezistentné kapsuly

Code 9681A
MA number EU/1/13/837/001
Product Form: cps end 14x120 mg (blis.PVC/PE/PVDC-PVC/alu)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AX Other immunosuppressants
L04AX07 Dimethyl fumarate
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
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