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PRODUCT DETAIL

Fingolimod FMK 0,5 mg tvrdé kapsuly

Code 6158D
MA number 59/0271/20-S
Product Form: cps dur 98x0,5 mg (blis.PVC/PE/PVDC/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: Farmak International Sp. z o.o., Poland
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AA Selective immunosuppressants
L04AA27 Fingolimod
Shelf life: 24
Container: blister PVC/PE/PVDC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 17.12.2020
Validity: 17.12.2025
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_Fingolimod FMK 0,5 mg tvrdé kapsuly_09.2023.pdf  
PIL: PIL_Fingolimod FMK 0,5 mg tvrdé kapsuly_09.2023.pdf  
Safety feature Yes
Data update: 13.09.2023
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