| Code | 8879D | ||||||||||
| MA number | 59/0261/21-S | ||||||||||
| Product Form: | cps dur 28x1x0,5 mg (blis.OPA/Al/PVC/Al-jednotliv.dáv.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Gedeon Richter Plc., Hungary | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 28.10.2021 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Fingolimod Richter_12.2021.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
|
| SPC: |
SPC_Fingolimod Richter 0,5 mg tvrdé kapsuly_02.2025.pdf
|
| Safety feature | Yes |
| Data update: | 21.03.2025 |
