Code | 32648 | ||||||||||
MA number | EU/1/01/188/003 | ||||||||||
Product Form: | plc ifc 10x35 mg (liek.inj.skl.) | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU | ||||||||||
MAH, country: | Sanofi B.V., Netherland | ||||||||||
Therapeutic Class: | 87 - VARIA I | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intravenous use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application |
MA issued: | 03.08.2001 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | Fabrazyme DHPC September_SK_approved.pdf |
Dokument: | Fabrazyme DHPC September_SK_approved.pdf |
Dokument: | DHCP Fabrazyme -19 2 2010_GIB.pdf |
Dokument: | DHCP Fabrazyme 26 4 2010_SK.pdf |
Dokument: | SK DHPC Fabrazyme 12 7 2010.pdf |
Safety feature | Yes |
Data update: | 23.07.2021 |