NAGLAZYME conc perf 5 mg/5ml flac 5 ml

7680582240013 CH-58224 A16AB08 07.14.0.
NAGLAZYME conc perf 5 mg/5ml flac 5 ml
NAGLAZYME conc perf 5 mg/5ml flac 5 ml
NAGLAZYME conc perf 5 mg/5ml flac 5 ml
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Details

Product number
5822401
CPT
-
Packaging group
1 x 5 ml
Unit
Durchstechflasche(n)
Composition
galsulfasum 5 mg, natrii chloridum, natrii dihydrogenophosphas monohydricus, dinatrii phosphas heptahydricus, polysorbatum 80, aqua ad iniectabile q.s., ad solutionem pro 5 ml corresp. natrium 18.4 mg.

Articles (1)

Naglazyme, Konzentrat zur Herstellung einer Infusionslösung
Konzentrat
1 x 5 ml
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
04/10/2022
Professional SmPC
Français
04/10/2022
Professional SmPC
Italien
04/10/2022

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)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
18.4 MG Substance HBESI

Reimbursement information

Public price
CHF 1462.50
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/10/2025

Authorization holder

DRAC AG

3280 Murten

Authorization information

Swissmedic authorization number
58224
Drug name
Naglazyme, Konzentrat zur Herstellung einer Infusionslösung
Galenic form
KOPA
ATC Code
A16AB08
Authorization status
Z
Dispensation category
B
First authorization
02/10/2007
Authorization expiration date
31/12/9999
IT number
07.14.0.
Domain
Human medicine
Field of application
Mukopolysaccharidose VI (Maroteaux-Lamy-Syndrom)

Packaging details

Description (FR)
NAGLAZYME conc perf 5 mg/5ml flac 5 ml
Description (DE)
NAGLAZYME Inf Konz 5 mg/5ml Durchstf 5 ml
Market launch
02/10/2007
Narcotic (BTM)
No