VIMIZIM conc perf 5 mg/5ml flac

7680653700019 CH-65370 A16AB12 07.14.0.
VIMIZIM conc perf 5 mg/5ml flac
VIMIZIM conc perf 5 mg/5ml flac
VIMIZIM conc perf 5 mg/5ml flac
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Details

Product number
6537001
CPT
-
Packaging group
1
Unit
Durchstechflasche(n)
Composition
elosulfasum alfa 5 mg, natrii acetas trihydricus, natrii dihydrogenophosphas monohydricus, arginini hydrochloridum, sorbitolum 100 mg, polysorbatum 20, aqua ad iniectabile q.s. ad solutionem pro 5 ml corresp. natrium 8 mg.

Articles (1)

Vimizim 5mg/5ml, Konzentrat zur Herstellung einer Infusionslösung
Konzentrat
1
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
23/04/2026
Professional SmPC
Français
23/04/2026
Professional SmPC
Italien
23/04/2026

Detailed composition

Substance Quantity Type Category
elosulfasum alfa
5.0 MG Substance Wirkstoff (Principe actif)
natrii acetas trihydricus
- Substance HNIDK
natrii dihydrogenophosphas monohydricus
- Substance HNIDK
arginini hydrochloridum
- Substance HNIDK
sorbitolum
100.0 MG Substance HBESI
polysorbatum 20
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK
natrium
8.0 MG Substance HBESI

Authorization holder

DRAC AG

3280 Murten

Authorization information

Swissmedic authorization number
65370
Drug name
Vimizim, Konzentrat zur Herstellung einer Infusionslösung
Galenic form
KOPA
ATC Code
A16AB12
Authorization status
Z
Dispensation category
B
First authorization
19/01/2016
Authorization expiration date
31/12/9999
IT number
07.14.0.
Domain
Human medicine
Field of application
Behandlung der Mucopolysaccharidose Typ IVA

Packaging details

Description (FR)
VIMIZIM conc perf 5 mg/5ml flac
Description (DE)
VIMIZIM Inf Konz 5 mg/5ml Durchstf
Market launch
19/01/2016
Narcotic (BTM)
No
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