Code | 7495D | ||||||||||
MA number | EU/1/06/346/002 | ||||||||||
Product Form: | sol inj 2x1 ml/150 mg (striek.inj.napl.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Biogen Netherlands B.V., Netherland | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Route of admin.: | Subcutaneous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 27.06.2006 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | DHPC Tysabri 18 3 2016.pdf |
Dokument: | DHPC Tysabri_DHPC 24 3 2010.pdf |
Dokument: | sk_Tysabri_Karta pre pacienta.pdf |
Dokument: | sk_Tysabri_Formulár o začatí liečby a pokračovaní v liečbe.pdf |
Dokument: | sk_Tysabri_Formulár o ukončení liečby.pdf |
Dokument: | sk_Tysabri_Kontrolný zoznam pred podaním lieku mimo OCS.pdf |
Dokument: | sk_Tysabri_Informácie pre lekárov a usmernenia k liečbe.pdf |
Dokument: | sk_Tysabri_Doplnkové informácie pre zdravotníckych pracovníkov.pdf |
Safety feature | Yes |
Data update: | 10.06.2024 |