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PRODUCT DETAIL

Fingolimod Glenmark 0,5 mg

Code 6089E
MA number 59/0075/21-S
Product Form: cps dur 28x1x0,5 mg (blis.PVC/PE/PVDC/Al-jednotk.bal.)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
Therapeutic Class: 59 - IMMUNOPRAEPARATA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04 Immunosuppressants
L04A Immunosuppressants
L04AE Sphingosine 1-phosphate (S1P) receptor modulators
L04AE01 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: 18.03.2021
Validity: 18.03.2026
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_Fingolimod Glenmark 0,5 mg_04.2024.pdf  
PIL: PIL_Fingolimod Glenmark 0,5 mg_04.2024.pdf  
Safety feature Yes
Data update: 25.04.2024
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