REFIXIA subst sèche 1000 UI c solv flac

7680662160026 CH-66216 B02BD04 06.01.1.

Active substances:

REFIXIA subst sèche 1000 UI c solv flac
Fiches Amavita / Sun Store / Coop Vitality

Details

Product number
6621602
CPT
-
Packaging group
-
Unit
(1 Durchstechflasche mit Pulver und 1 Fertigspritze mit Lösungsmittel) und Verabreichungsset
Composition
Praeparatio cryodesiccata: nonacogum beta pegolum 1000 U.I., natrii chloridum, histidinum, saccharum 10 mg, mannitolum, polysorbatum 80, natrii hydroxidum ad pH, acidum hydrochloridum ad pH, pro vitro corresp. natrium 0.972 mg/ml. Solvens: histidinum, natrii hydroxidum ad pH, acidum hydrochloridum ad pH, aqua ad iniectabile q.s. ad solutionem pro 1 ml corresp. natrium.

Articles (1)

Refixia 1000 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Pulver
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
29/01/2025
Patient information leaflet
Français
29/01/2025
Patient information leaflet
Italien
29/01/2025
Professional SmPC
Allemand
29/01/2025
Professional SmPC
Français
29/01/2025
Professional SmPC
Italien
29/01/2025

Detailed composition

Substance Quantity Type Category
histidinum
- Substance HNIDK
nonacogum beta pegolum
1000.0 UI Substance Wirkstoff (Principe actif)
natrii hydroxidum
- Substance HNIDK
natrii chloridum
- Substance HNIDK
acidum hydrochloridum
- Substance HNIDK
histidinum
- Substance HNIDK
saccharum
10.0 MG Substance HBESI
aqua ad iniectabile
- Substance HNIDK
mannitolum
- Substance HNIDK
natrium
- Substance HBESI
polysorbatum 80
- Substance HNIDK
natrii hydroxidum
- Substance HNIDK
acidum hydrochloridum
- Substance HNIDK
natrium
0.972 MGML Substance HBESI

Reimbursement information

Public price
CHF 1866.05
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/11/2017

Authorization holder

Novo Nordisk Pharma AG

8302 Kloten

Authorization information

Swissmedic authorization number
66216
Drug name
Refixia, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Galenic form
PULMJ
ATC Code
B02BD04
Authorization status
Z
Dispensation category
B
First authorization
05/09/2017
Authorization expiration date
31/12/9999
IT number
06.01.1.
Domain
Human medicine
Field of application
Hämophilie B

Packaging details

Description (FR)
REFIXIA subst sèche 1000 UI c solv flac
Description (DE)
REFIXIA Trockensub 1000 IE c Solv Durchstf
Market launch
05/09/2017
Narcotic (BTM)
No

Other packaging sizes

REFIXIA subst sèche 500 UI c solv flac
None LEER
View
REFIXIA subst sèche 2000 UI c solv flac
None LEER
View
REFIXIA subst sèche 3000 UI c solv flac
None LEER
View
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