AFSTYLA subst sèche 500 UI c solv+set flac

7680660300103 CH-66030 B02BD02 06.01.1.

Reimbursement limitations:

AFSTYLA

Traitement et prophylaxie d'épisodes hémorragiques chez des patients atteints d'hémophilie A (déficit congénital en facteur …

AFSTYLA subst sèche 500 UI c solv+set flac
AFSTYLA subst sèche 500 UI c solv+set flac
AFSTYLA subst sèche 500 UI c solv+set flac
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Details

Product number
6603003
CPT
-
Packaging group
500
Unit
I.E.
Composition
Praeparatio cryodesiccata: lonoctocogum alfa 500 U.I., histidinum, polysorbatum 80, calcii chloridum dihydricum, natrii chloridum corresp. natrium 16.1 mg, saccharum, acidum hydrochloridum, pro vitro. Solvens: aqua ad iniectabile 2.5 ml pro vitro.

Articles (1)

Afstyla 500 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Pulver
500
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
SOLV
2.5 ML Substance HNIDK
PRC
500.0 UI Substance Wirkstoff (Principe actif)
PRC
- Substance HNIDK
PRC
- Substance HNIDK
PRC
- Substance HNIDK
PRC
- Substance HNIDK
PRC
16.1 MG Substance HBESI
PRC
- Substance HNIDK
PRC
- Substance HNIDK

Reimbursement information

Public price
CHF 403.70
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 subst sèche 500 UI c solv+set flac
Description (DE)
AFSTYLA Trockensub 500 IE c Solv+Set Durchstf
Market launch
07/04/2017
Narcotic (BTM)
No

Other packaging sizes

AFSTYLA subst sèche 1000 UI c solv+set flac
1000 IE
View
AFSTYLA subst sèche 2000 UI c solv+set flac
2000 IE
View