Code | 06615 | ||||||||||
MA number | EU/1/11/677/001 | ||||||||||
Product Form: | cps dur 7x1x0,5 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: |
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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 8(3) application - new active substance |
MA issued: | 17.03.2011 |
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 |
Safety feature | Yes |
Data update: | 26.11.2020 |