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PRODUCT DETAIL

Fingolimod Mylan 0,5 mg tvrdé kapsuly

Code 8576D
MA number EU/1/21/1573/014
Product Form: cps dur 7x1x0,5 mg (blis.PVC/PE/PVDC/Al - jednotk.dáv.)
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
L04AA Selective immunosuppressants
L04AA27 Fingolimod
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: 18.08.2021
Validity: 18.08.2026
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 10.09.2021
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