ANDEMBRY 200 mg sol inj stylo autoinj

7680695530018 CH-69553 B06AC07 02.99.0.

Active substances:

ANDEMBRY 200 mg sol inj stylo autoinj
ANDEMBRY 200 mg sol inj stylo autoinj
ANDEMBRY 200 mg sol inj stylo autoinj
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Details

GTIN
7680695530018
Pharmacode
-
Product number
6955301
CPT
-
Packaging group
1
Unit
Fertigpen
Composition
garadacimabum 200 mg, histidinum, arginini hydrochloridum, prolinum 19.3 mg, polysorbatum 80 0.24 mg, aqua ad iniectabile q.s. ad solutionem pro 1.2 ml.

Articles (1)

Andembry 200 mg, Injektionslösung im Fertigpen
Injektionslösung im Fertigpen
1
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
19/03/2025
Professional SmPC
Français
19/03/2025
Professional SmPC
Italien
19/03/2025
Patient information leaflet
Allemand
12/03/2025
Patient information leaflet
Français
12/03/2025
Patient information leaflet
Italien
12/03/2025

Detailed composition

Substance Quantity Type Category
garadacimabum
200.0 MG Substance Wirkstoff (Principe actif)
histidinum
- Substance HNIDK
arginini hydrochloridum
- Substance HNIDK
prolinum
- Substance HNIDK
polysorbatum 80
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK

Reimbursement information

Public price
CHF 16158.45
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/09/2025

Authorization holder

CSL Behring AG

3014 Bern

Authorization information

Swissmedic authorization number
69553
Drug name
Andembry, Injektionslösung im Fertigpen
Galenic form
INLFP
ATC Code
B06AC07
Authorization status
Z
Dispensation category
B
First authorization
24/02/2025
Authorization expiration date
23/02/2030
IT number
02.99.0.
Domain
Human medicine
Field of application
Langzeitprophylaxe wiederkehrender akuter Schübe des hereditären Angioödems (HAE) bei erwachsenen und pädiatrischen Patienten ab 12 Jahren.

Packaging details

Description (FR)
ANDEMBRY 200 mg sol inj stylo autoinj
Description (DE)
ANDEMBRY 200 mg Inj Lsg AI
Market launch
01/07/2025
Narcotic (BTM)
No
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