| Code | 8564D | ||||||||||
| MA number | EU/1/21/1573/002 | ||||||||||
| Product Form: | cps dur 28x1x0,5 mg (blis.PVC/PCTFE/Al - jednotk.dáv.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Mylan Pharmaceuticals Limited, Ireland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| 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: | 18.08.2021 |
| Validity: | 18.08.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| 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: | 16.04.2025 |
