AFSTYLA 2000 UI pdr et solv p sol inj

7680660300134 CH-66030 B02BD02 06.01.1.

Active substances:

AFSTYLA 2000 UI pdr et solv p sol inj
AFSTYLA 2000 UI pdr et solv p sol inj
AFSTYLA 2000 UI pdr et solv p sol inj
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Details

Product number
6603006
CPT
-
Packaging group
2000
Unit
I.E.
Composition
Praeparatio cryodesiccata: lonoctocogum alfa 2000 U.I., histidinum, polysorbatum 80, calcii chloridum dihydricum, natrii chloridum corresp. natrium 32.3 mg, saccharum, acidum hydrochloridum, pro vitro. Solvens: aqua ad iniectabile 5 ml pro vitro.

Articles (1)

Afstyla 2000 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Pulver
2000
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
02/11/2023
Professional SmPC
Français
02/11/2023
Professional SmPC
Italien
02/11/2023

Detailed composition

Substance Quantity Type Category
aqua ad iniectabile
5.0 ML Substance HNIDK
lonoctocogum alfa
2000.0 UI Substance Wirkstoff (Principe actif)
histidinum
- Substance HNIDK
polysorbatum 80
- Substance HNIDK
calcii chloridum dihydricum
- Substance HNIDK
natrii chloridum
- Substance HNIDK
natrium
32.3 MG Substance HBESI
saccharum
- Substance HNIDK
acidum hydrochloridum
- Substance HNIDK

Reimbursement information

Public price
CHF 1489.45
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/05/2017

Authorization holder

CSL Behring Lengnau AG

2543 Lengnau BE

Authorization information

Swissmedic authorization number
66030
Drug name
Afstyla, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Galenic form
PULMJ
ATC Code
B02BD02
Authorization status
Z
Dispensation category
B
First authorization
07/04/2017
Authorization expiration date
31/12/9999
IT number
06.01.1.
Domain
Human medicine
Field of application
Behandlung und Prophylaxe von Blutungen bei vorbehandelten Patienten mit Haemophilie A (Faktor VIII Mangel)

Packaging details

Description (FR)
AFSTYLA 2000 UI pdr et solv p sol inj
Description (DE)
AFSTYLA 2000 I.E. Pulv und Lsm zur Inj Lsg
Market launch
07/04/2017
Narcotic (BTM)
No

Other packaging sizes

AFSTYLA 2000 UI pdr et solv p sol inj
500 IE
View
AFSTYLA 1000 UI pdr et solv p sol inj
1000 IE
View
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