| Code | 0337D | ||||||||||
| MA number | EU/1/11/677/007 | ||||||||||
| Product Form: | cps dur 7x1x0,25 mg (blis.PVC/PVDC/Al-jednotk.bal.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Novartis Europharm Limited, Ireland | ||||||||||
| Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 18 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 22.11.2018 |
| SmPC + PL: |
European Medicines Agency's database
|
| Dokument: |
DHPC Gilenya 4 1 2016.pdf
|
| Dokument: |
DHPC Gilenya 28 4 2015.pdf
|
| Dokument: |
DHPC Gilenya 11 11 2013.pdf
|
| Dokument: |
Gilenya - DHPC (Dec 2012) SK_Final.pdf
|
| Dokument: |
DHPC_Gilenya_24 1 2012.pdf
|
| Dokument: |
DHPC_Gilenya_26 4 2012.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: | 26.11.2020 |
