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
04/02/2020
Professional SmPC
Français
04/02/2020
Professional SmPC
Italien
04/02/2020

Detailed composition

Substance Quantity Type Category
(N/A)
5.0 MG Substance Wirkstoff (Principe actif)
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
100.0 MG Substance HBESI
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
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