| Code | 5638D | ||||||||||
| MA number | 59/0223/20-S | ||||||||||
| Product Form: | cps dur 98x1x0,5 mg (blis.PVC/PVDC/Al-jednotliv.dáv.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 27.10.2020 |
| Validity: | 27.10.2025 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Fingolimod STADA 0,5 mg tvrdé kapsuly_09.2021.pdf
|
| PIL: |
PIL_Fingolimod STADA 0,5 mg tvrdé kapsuly_09.2021.pdf
|
| Safety feature | Yes |
| Data update: | 04.11.2020 |
