BENEFIX subst sèche 500 UI c solv flac 5 ml

7680545100422 CH-54510 B02BD04 06.01.1.

Active substances:

BENEFIX subst sèche 500 UI c solv flac 5 ml
BENEFIX subst sèche 500 UI c solv flac 5 ml
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Fiches Amavita / Sun Store / Coop Vitality

Details

Product number
5451002
CPT
-
Packaging group
-
Unit
1 Durchstechflasche mit Pulver und 1 Fertigspritze mit Lösungsmittel und Zubehör
Composition
Praeparatio cryodesiccata: nonacogum alfa 500 U.I., histidinum, glycinum, saccharum, polysorbatum 80, acidum hydrochloridum, pro vitro. Solvens: natrii chloridum, aqua ad iniectabile q.s. ad solutionem pro 5 ml corresp. natrium 4.6 mg.

Articles (1)

BeneFIX 500, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Pulver
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
18/03/2026
Professional SmPC
Français
18/03/2026
Professional SmPC
Italien
18/03/2026

Detailed composition

Substance Quantity Type Category
natrii chloridum
- Substance HNIDK
nonacogum alfa
500.0 UI Substance Wirkstoff (Principe actif)
aqua ad iniectabile
- Substance HNIDK
histidinum
- Substance HNIDK
glycinum
- Substance HNIDK
natrium
4.6 MG Substance HBESI
saccharum
- Substance HNIDK
polysorbatum 80
- Substance HNIDK
acidum hydrochloridum
- Substance HNIDK

Reimbursement information

Public price
CHF 407.75
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 15/03/1998

Authorization holder

Pfizer AG

8052 Zürich

Authorization information

Swissmedic authorization number
54510
Drug name
BeneFIX, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Galenic form
PULMJ
ATC Code
B02BD04
Authorization status
Z
Dispensation category
B
First authorization
26/02/1998
Authorization expiration date
31/12/9999
IT number
06.01.1.
Domain
Human medicine
Field of application
Hämophilie B

Packaging details

Description (FR)
BENEFIX subst sèche 500 UI c solv flac 5 ml
Description (DE)
BENEFIX Trockensub 500 IE c Solv Durchstf 5 ml
Market launch
26/02/1998
Narcotic (BTM)
No

Other packaging sizes

BENEFIX subst sèche 250 UI c solv flac 5 ml
None LEER
View
BENEFIX subst sèche 1000 UI c solv flac 5 ml
None LEER
View
BENEFIX subst sèche 2000 UI c solv flac 5 ml
None LEER
View
BENEFIX subst sèche 3000 UI c solv flac 5 ml
None LEER
View
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