CALQUENCE caps 100 mg 60 pce

7680677900013 CH-67790 L01EL02 07.16.1.
CALQUENCE caps 100 mg 60 pce
CALQUENCE caps 100 mg 60 pce
CALQUENCE caps 100 mg 60 pce
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Details

Product number
6779001
CPT
-
Packaging group
60
Unit
Kapsel(n)
Composition
acalabrutinibum 100 mg, cellulosum microcristallinum silicificatum, amylum pregelificatum, carboxymethylamylum natricum A corresp. natrium max. 0.25 mg, magnesii stearas, Kapselhülle: gelatina, E 172 (flavum), E 132, E 171, Drucktinte: lacca, E 172 (nigrum), propylenglycolum, ammonii hydroxidum, pro capsula.

Articles (1)

Calquence 100 mg, Hartkapseln
Kapseln
60
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
02/12/2024
Professional SmPC
Français
02/12/2024
Professional SmPC
Italien
02/12/2024
Patient information leaflet
Allemand
23/08/2022
Patient information leaflet
Français
23/08/2022
Patient information leaflet
Italien
23/08/2022

Detailed composition

Substance Quantity Type Category
(N/A)
100.0 MG Substance Wirkstoff (Principe actif)
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HBESI
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance FTODK
(N/A)
- Substance FIMDK
(N/A)
- Substance FNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance FTODK
(N/A)
- Substance Hilfsstoff ohne Deklarationspflicht (Excipient sans obligation de déclaration)
(N/A)
- Substance HNIDK

Authorization holder

AstraZeneca AG

6340 Baar

Authorization information

Swissmedic authorization number
67790
Drug name
Calquence, Hartkapseln
Galenic form
KAHA
ATC Code
L01EL02
Authorization status
Z
Dispensation category
A
First authorization
04/03/2021
Authorization expiration date
03/03/2026
IT number
07.16.1.
Domain
Human medicine
Field of application
chronisch lymphatische Leukämie (CLL)

Packaging details

Description (FR)
CALQUENCE caps 100 mg 60 pce
Description (DE)
CALQUENCE Kaps 100 mg 60 Stk
Market launch
04/03/2021
Narcotic (BTM)
No