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PRODUCT DETAIL

Fingolimod Pharmaselect 0,5 mg tvrdé kapsuly

Code 6871E
MA number 59/0181/24-S
Product Form: cps dur 7x0,5 mg (blis. PVC/PE/PVDC/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: Pharmaselect International Beteiligungs GmbH, Austria
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: 14.08.2024
Validity: 14.08.2029
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL_Fingolimod Pharmaselect 0,5 mg tvrdé kapsuly_07 2024.pdf  
SPC: SPC_Fingolimod Pharmaselect 0,5 mg tvrdé kapsuly_07 2024.pdf  
Safety feature Yes
Data update: 23.08.2024
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