| Code | 1312F | ||||||||||
| MA number | 59/0324/25-S | ||||||||||
| Product Form: | cps dur 14x0,5 mg (blis.PVC/PE/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | AS Olpha, Latvia | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 10.10.2025 |
| Validity: | 10.10.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Fingolimod Olpha 0,5 mg tvrdé kapsuly_cps dur_10/2025_REG.pdf
|
| PIL: |
PIL_Fingolimod Olpha 0,5 mg tvrdé kapsuly_cps dur_10/2025_REG.pdf
|
| Safety feature | Yes |
| Data update: | 17.10.2025 |
