| Code | 7380D | ||||||||||
| MA number | 59/0116/21-S | ||||||||||
| Product Form: | cps dur 98x0,5 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Bausch Health Ireland Limited , Ireland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
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| 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: | 14.05.2021 |
| Validity: | 14.05.2026 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| Dokument: |
Fingolimod_Prirucka-pre-pacienta_rodica_opatrovatela_V1_2024.pdf
|
| Dokument: |
Fingolimod_Kontrolný zoznam pre lekára_V1_2024.pdf
|
| Dokument: |
Fingolimod_Karta pacientky_V1_2024.pdf
|
| SPC: |
SPC_Gaxenim 0,5 mg_04.2025.pdf
|
| PIL: |
PIL_Gaxenim 0,5 mg_04.2025.pdf
|
| Safety feature | Yes |
| Data update: | 11.10.2024 |
