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PRODUCT DETAIL

Efigalo 0,5 mg tvrdé kapsuly

Code 7269D
MA number 59/0102/21-S
Product Form: cps dur 14x1x0,5 mg (blis.OPA/Al/PVC/Al-jednotliv.dáv.- kal.balenie)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AA Selective immunosuppressants
L04AA27 Fingolimod
Shelf life: 36
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 30.03.2021
Validity: 30.03.2026
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL_Efigalo 0,5 mg tvrdé kapsuly_01.2023.pdf  
SPC: SPC_Efigalo 05 mg tvrdé kapsuly_11.2023.pdf  
Safety feature Yes
Data update: 06.11.2023
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