| Code | 5489D | ||||||||||
| MA number | 59/0196/20-S | ||||||||||
| Product Form: | cps dur 28x0,5 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PE/PVDC/Al | ||||||||||
| Route of admin.: | Oromucosal use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 17.09.2020 |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Bonaxon_04.2022.pdf
|
| PIL: |
PIL_Bonaxon_04.2022.pdf
|
| 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
|
| Safety feature | Yes |
| Data update: | 07.03.2025 |
