KAPRUVIA sol inj 50 µg 1 ml 3 pce flac

7680686530010 CH-68653 V03AX04 05.99.0.

Active substances:

KAPRUVIA sol inj 50 µg 1 ml 3 pce flac
KAPRUVIA sol inj 50 µg 1 ml 3 pce flac
KAPRUVIA sol inj 50 µg 1 ml 3 pce flac
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Details

GTIN
7680686530010
Pharmacode
-
Product number
6865301
CPT
-
Packaging group
3 x 1 ml
Unit
Durchstechflasche(n)
Composition
difelikefalinum 50 µg ut difelikefalini acetas, acidum aceticum, natrii acetas trihydricus, natrii chloridum, aqua ad iniectabile, q.s. ad solutionem pro 1 ml corresp. natrium 3.3 mg.

Articles (1)

Kapruvia 50 µg/ml, Injektionslösung
Injektionslösung
3 x 1 ml
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
19/07/2024
Professional SmPC
Français
19/07/2024
Professional SmPC
Italien
19/07/2024

Detailed composition

Substance Quantity Type Category
difelikefalinum
50.0 UG Substance Wirkstoff (Principe actif)
difelikefalini acetas
- Substance WIZUS
acidum aceticum
- Substance HNIDK
natrii acetas trihydricus
- Substance HNIDK
natrii chloridum
- Substance HNIDK
aqua ad iniectabile
- Substance HNIDK
natrium
3.3 MG Substance HBESI

Authorization holder

Vifor Fresenius Medical Care

9014 St. Gallen

Authorization information

Swissmedic authorization number
68653
Drug name
Kapruvia, Injektionslösung
Galenic form
LSINJ
ATC Code
V03AX04
Authorization status
Z
Dispensation category
B
First authorization
16/08/2022
Authorization expiration date
15/08/2027
IT number
05.99.0.
Domain
Human medicine
Field of application
Behandlung von Pruritus in Zusammenhang mit chronischen Nierenerkrankungen bei erwachsenen Patienten unter Hämodialyse

Packaging details

Description (FR)
KAPRUVIA sol inj 0.05 mg/ml 3 flac 1 ml
Description (DE)
KAPRUVIA Inj Lös 0.05 mg/ml 3 Durchstf 1 ml
Market launch
16/08/2022
Narcotic (BTM)
No

Other packaging sizes

KAPRUVIA sol inj 0.05 mg/ml 12 flac 1 ml
12 x 1 ml DUR
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