Nilotinib Spirig HC 50 mg, Hartkapseln

7680697710012 CH-69771 L01X 07.16.1.
Nilotinib Spirig HC 50 mg, Hartkapseln
Nilotinib Spirig HC 50 mg, Hartkapseln
Nilotinib Spirig HC 50 mg, Hartkapseln
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Details

Product number
6977101
CPT
-
Packaging group
120
Unit
Kapsel(n)
Composition
nilotinibum 50 mg ut nilotinibi hydrochloridum dihydricum, lactosum monohydricum 36.66 mg, crospovidonum, silica colloidalis anhydrica, magnesii stearas, Kapselhülle: hypromellosum, aqua purificata, carrageenanum, kalii chloridum, E 127, E 172 (flavum), E 172 (rubrum), E 171, Drucktinte: lacca, propylenglycolum, kalii hydroxidum, E 172 (nigrum), pro capsula.

Articles (1)

Nilotinib Spirig HC 50 mg, Hartkapseln
Kapseln
120
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
02/09/2025
Patient information leaflet
Français
02/09/2025
Patient information leaflet
Italien
02/09/2025
Professional SmPC
Allemand
02/09/2025
Professional SmPC
Français
02/09/2025
Professional SmPC
Italien
02/09/2025

Detailed composition

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

Authorization holder

Spirig HealthCare AG

4622 Egerkingen

Authorization information

Swissmedic authorization number
69771
Drug name
Nilotinib Spirig HC, Hartkapseln
Galenic form
KAHA
ATC Code
L01X
Authorization status
Z
Dispensation category
A
First authorization
16/04/2025
Authorization expiration date
15/04/2030
IT number
07.16.1.
Domain
Human medicine
Field of application
Antineoplastika > Proteinkinase-Inhibitoren (myeloische Leukämie)

Packaging details

Description (FR)
NILOTINIB Spirig HC caps 50 mg 120 pce
Description (DE)
NILOTINIB Spirig HC Kaps 50 mg 120 Stk
Market launch
15/10/2025
Narcotic (BTM)
No

Available generics

Nilotinib Spirig HC, Hartkapseln
CHF 1036.95
View
Nilotinib Spirig HC, Hartkapseln
CHF 484.75
View

Other packaging sizes

NILOTINIB Spirig HC caps 150 mg 112 pce
112 KAP
View
NILOTINIB Spirig HC caps 200 mg 28 pce
28 KAP
View