ALPROLIX subst sèche 1000 UI cum solv flac

7680660390036 CH-66039 B02BD04 06.01.1.

Active substances:

ALPROLIX subst sèche 1000 UI cum solv flac
ALPROLIX subst sèche 1000 UI cum solv flac
1 / 2
Fiches Amavita / Sun Store / Coop Vitality

Details

Product number
6603903
CPT
-
Packaging group
-
Unit
(1 Durchstechflasche mit Pulver und 1 Fertigspritze mit Lösungsmittel) und Verabreichungsset
Composition
Praeparatio cryodesiccata: eftrenonacogum alfa 1000 U.I., histidinum, mannitolum, saccharum, polysorbatum 20, acidum hydrochloridum aut natrii hydroxidum ad pH, pro vitro. Solvens: natrii chloridum, aqua ad iniectabile q.s. ad solutionem pro 5 ml corresp. natrium 6.4 mg.

Articles (1)

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

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
04/11/2025
Professional SmPC
Français
04/11/2025
Professional SmPC
Italien
04/11/2025

Detailed composition

Substance Quantity Type Category
natrii chloridum
- Substance HNIDK
eftrenonacogum alfa
1000.0 UI Substance Wirkstoff (Principe actif)
histidinum
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK
mannitolum
- Substance HNIDK
saccharum
- Substance HNIDK
natrium
6.4 MG Substance HBESI
polysorbatum 20
- Substance HNIDK
acidum hydrochloridum
- Substance HNIDK
natrii hydroxidum
- Substance HNIDK

Reimbursement information

Public price
CHF 1344.20
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/01/2017

Authorization holder

Swedish Orphan Biovitrum AG

4058 Basel

Authorization information

Swissmedic authorization number
66039
Drug name
Alprolix, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Galenic form
PULMJ
ATC Code
B02BD04
Authorization status
Z
Dispensation category
B
First authorization
25/10/2016
Authorization expiration date
31/12/9999
IT number
06.01.1.
Domain
Human medicine
Field of application
Behandlung und Prophylaxe von Blutungen bei Patienten mit Hämophilie B (kongenitaler Faktor IX-Mangel).

Packaging details

Description (FR)
ALPROLIX subst sèche 1000 UI cum solv flac
Description (DE)
ALPROLIX Trockensub 1000 IE cum Solv Durchstf
Market launch
25/10/2016
Narcotic (BTM)
No

Other packaging sizes

ALPROLIX subst sèche 250 UI cum solv flac
None LEER
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ALPROLIX subst sèche 500 UI cum solv flac
None LEER
View
ALPROLIX subst sèche 2000 UI cum solv flac
None LEER
View
ALPROLIX subst sèche 3000 UI c solv flac
None LEER
View
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