IDELVION 3500 UI pdr et solv p sol inj

7680657430097 CH-65743 B02BD04 06.01.1.

Active substances:

IDELVION 3500 UI pdr et solv p sol inj
IDELVION 3500 UI pdr et solv p sol inj
IDELVION 3500 UI pdr et solv p sol inj
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Details

Product number
6574305
CPT
-
Packaging group
3500
Unit
I.E.
Composition
Praeparatio cryodesiccata: albutrepenonacogum alfa 3500 U.I., saccharum, polysorbatum 80, mannitolum, trinatrii citras dihydricus corresp. natrium 8.6 mg, acidum hydrochloridum, pro vitro. Solvens: aqua ad iniectabile 5 ml pro vitro.

Articles (1)

Idelvion 3500 IU, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Pulver
3500
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
16/05/2026
Professional SmPC
Français
16/05/2026
Professional SmPC
Italien
16/05/2026

Detailed composition

Substance Quantity Type Category
aqua ad iniectabile
5.0 ML Substance HNIDK
albutrepenonacogum alfa
3500.0 UI Substance Wirkstoff (Principe actif)
saccharum
- Substance HNIDK
polysorbatum 80
- Substance HNIDK
mannitolum
- Substance HNIDK
trinatrii citras dihydricus
- Substance HNIDK
natrium
8.6 MG Substance HBESI
acidum hydrochloridum
- Substance HNIDK

Reimbursement information

Public price
CHF 7643.40
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/07/2021

Authorization holder

CSL Behring Lengnau AG

2543 Lengnau BE

Authorization information

Swissmedic authorization number
65743
Drug name
Idelvion, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Galenic form
PULMJ
ATC Code
B02BD04
Authorization status
Z
Dispensation category
B
First authorization
30/08/2016
Authorization expiration date
31/12/9999
IT number
06.01.1.
Domain
Human medicine
Field of application
Behandlung und Blutungsprophylaxe bei Patienten mit Haemophilie B (Faktor IX Mangel)

Packaging details

Description (FR)
IDELVION 3500 UI pdr et solv p sol inj
Description (DE)
IDELVION 3500 I.E. Pulv und Lsm zur Inj Lsg
Market launch
26/11/2020
Narcotic (BTM)
No

Other packaging sizes

IDELVION 250 UI pdr et solv p sol inj
250 IE
View
IDELVION 500 UI pdr et solv p sol inj
500 IE
View
IDELVION 1000 UI pdr et solv p sol inj
1000 IE
View
IDELVION 2000 UI pdr et solv p sol inj
2000 IE
View
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