| Code | 0677E | ||||||||||
| MA number | 59/0138/22-S | ||||||||||
| Product Form: | cps dur 56x0,5 mg (blis.PVC/PCTFE/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Reddy Holding GmbH, Germany | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PCTFE/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 24.05.2022 |
| Validity: | 24.05.2027 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Fingolimod Reddy 0,5 mg cps dur_05 2022.pdf
|
| PIL: |
PIL_Fingolimod Reddy 0,5 mg cps dur_02.2024.pdf
|
| Dokument: |
Fingolimod_Karta pacientky_V1_2025.pdf
|
| Dokument: |
Fingolimod_Kontrolny zoznam pre lekara_V1_2025.pdf
|
| Dokument: |
Fingolimod_Prirucka-pre-pacienta_rodica_opatrovatela_V1_2025.pdf
|
| Safety feature | Yes |
| Data update: | 21.11.2022 |
