ELAPRASE conc perf 6 mg/3ml flac 3 ml

7680579160010 CH-57916 A16AB09 07.14.0.
ELAPRASE conc perf 6 mg/3ml flac 3 ml
ELAPRASE conc perf 6 mg/3ml flac 3 ml
ELAPRASE conc perf 6 mg/3ml flac 3 ml
1 / 3
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Details

Product number
5791601
CPT
-
Packaging group
1
Unit
Durchstechflasche(n)
Composition
idursulfasum 2 mg, natrii chloridum, dinatrii phosphas heptahydricus, natrii dihydrogenophosphas monohydricus, polysorbatum 20, aqua ad iniectabile q.s. ad solutionem pro 1 ml corresp. natrium 3.7 mg.

Articles (1)

Elaprase 2 mg/ml, Infusionskonzentrat
Infusionskonzentrat
1
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
17/10/2025
Professional SmPC
Français
17/10/2025
Professional SmPC
Italien
17/10/2025
Patient information leaflet
Allemand
05/07/2022
Patient information leaflet
Français
05/07/2022
Patient information leaflet
Italien
05/07/2022

Detailed composition

Substance Quantity Type Category
(N/A)
2.0 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)
3.7 MG Substance HBESI

Reimbursement information

Public price
CHF 2822.55
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/10/2025

Authorization holder

Takeda Pharma AG

8152 Opfikon

Authorization information

Swissmedic authorization number
57916
Drug name
Elaprase, Konzentrat zur Herstellung einer Infusionslösung
Galenic form
KOINF
ATC Code
A16AB09
Authorization status
Z
Dispensation category
A
First authorization
20/03/2007
Authorization expiration date
31/12/9999
IT number
07.14.0.
Domain
Human medicine
Field of application
Langzeitbehandlung von Patienten mit Hunter-Syndrom (Mukopolysaccharidose II, MPS II)

Packaging details

Description (FR)
ELAPRASE conc perf 6 mg/3ml flac 3 ml
Description (DE)
ELAPRASE Inf Konz 6 mg/3ml Durchstf 3 ml
Market launch
20/03/2007
Narcotic (BTM)
No