| Code | 32646 | ||||||||||
| MA number | EU/1/01/188/001 | ||||||||||
| Product Form: | plc ifc 1x35 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 |
