| Code | 7100D | ||||||||||
| MA number | 59/0101/21-S | ||||||||||
| Product Form: | cps dur 30x0,5 mg (blis.OPA/Al/PVC/papier/PET/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | TEVA Pharmaceuticals Slovakia s.r.o., Slovakia | ||||||||||
| 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: | 01.04.2021 |
| Validity: | 01.04.2026 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_LOGNIF 0,5 mg_cps dur_09.2021.pdf
|
| SPC: |
SPC_LOGNIF 0,5 mg tvrdé kapsuly_07.2024.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
|
| Safety feature | Yes |
| Data update: | 03.07.2024 |
