REPLAGAL conc perf 3.5 mg/3.5ml flac 3.5 ml

7680557740012 CH-55774 A16AB03 07.14.0.
REPLAGAL conc perf 3.5 mg/3.5ml flac 3.5 ml
REPLAGAL conc perf 3.5 mg/3.5ml flac 3.5 ml
REPLAGAL conc perf 3.5 mg/3.5ml flac 3.5 ml
1 / 3
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Details

Product number
5577401
CPT
-
Packaging group
1
Unit
Durchstechflasche(n)
Composition
agalsidasum alfa 1 mg, natrii dihydrogenophosphas monohydricus, polysorbatum 20, natrii chloridum, natrii hydroxidum q.s. ad pH, aqua ad iniectabile q.s. ad solutionem pro 1 ml corresp. natrium 4.1 mg.

Articles (1)

Replagal Durchstechflasche à 3.5 mL, Infusionskonzentrat
Infusionskonzentrat
1
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
06/04/2022
Professional SmPC
Français
06/04/2022
Professional SmPC
Italien
06/04/2022
Patient information leaflet
Allemand
04/04/2022
Patient information leaflet
Français
04/04/2022
Patient information leaflet
Italien
04/04/2022

Detailed composition

Substance Quantity Type Category
(N/A)
1.0 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)
4.1 MG Substance HBESI

Reimbursement information

Public price
CHF 1960.85
Specialties list
Yes
Generic
No
SL addition date: 01/07/2002

Authorization holder

Takeda Pharma AG

8152 Opfikon

Authorization information

Swissmedic authorization number
55774
Drug name
Replagal, Infusionskonzentrat
Galenic form
KOINF
ATC Code
A16AB03
Authorization status
Z
Dispensation category
A
First authorization
28/12/2001
Authorization expiration date
31/12/9999
IT number
07.14.0.
Domain
Human medicine
Field of application
Enzymersatz-Therapie bei Patienten mit Morbus Fabry (alfa-Galaktosidase-A-Mangel)

Packaging details

Description (FR)
REPLAGAL conc perf 3.5 mg/3.5ml flac 3.5 ml
Description (DE)
REPLAGAL Inf Konz 3.5 mg/3.5ml Durchstf 3.5 ml
Market launch
28/12/2001
Narcotic (BTM)
No

Other packaging sizes