NILOTINIB Spirig HC caps 200 mg 112 pce

7680697710043 CH-69771 L01X 07.16.1.

Active substances:

No images available

Details

Product number
6977103
CPT
-
Packaging group
112
Unit
Kapsel(n)
Composition
nilotinibum 200 mg ut nilotinibi hydrochloridum dihydricum, lactosum monohydricum 146.62 mg, crospovidonum, silica colloidalis anhydrica, magnesii stearas, Kapselhülle: hypromellosum, aqua purificata, carrageenanum, kalii chloridum, E 172 (flavum), E 171, Drucktinte: lacca, propylenglycolum, kalii hydroxidum, E 172 (nigrum), pro capsula.

Articles (1)

Nilotinib Spirig HC 200 mg, Hartkapseln
Kapseln
112
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
06/11/2025
Professional SmPC
Français
06/11/2025
Professional SmPC
Italien
06/11/2025
Patient information leaflet
Allemand
02/09/2025
Patient information leaflet
Français
02/09/2025
Patient information leaflet
Italien
02/09/2025

Detailed composition

Substance Quantity Type Category
nilotinibum
200.0 MG Substance Wirkstoff (Principe actif)
nilotinibi hydrochloridum dihydricum
- Substance WIZUS
lactosum monohydricum
146.62 MG Substance HBESI
crospovidonum
- Substance HNIDK
silica colloidalis anhydrica
- Substance HNIDK
magnesii stearas
- Substance HNIDK
hypromellosum
- Substance HNIDK
aqua purificata
- Substance HNIDK
carrageenanum
- Substance HNIDK
kalii chloridum
- Substance HNIDK
E 172 (flavum)
- Substance FTODK
E 171
- Substance FNIDK
lacca
- Substance HNIDK
propylenglycolum
- Substance Hilfsstoff ohne Deklarationspflicht (Excipient sans obligation de déclaration)
kalii hydroxidum
- Substance HNIDK
E 172 (nigrum)
- Substance FTODK

Reimbursement information

Public price
CHF 1552.60
Specialties list
Yes
Generic
Yes

Reimbursement limitation

SL addition date: 01/09/2025

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 200 mg 112 pce
Description (DE)
NILOTINIB Spirig HC Kaps 200 mg 112 Stk
Market launch
03/03/2026
Narcotic (BTM)
No

Other packaging sizes

NILOTINIB Spirig HC caps 50 mg 120 pce
120 KAP
View
NILOTINIB Spirig HC caps 150 mg 112 pce
112 KAP
View
NILOTINIB Spirig HC caps 200 mg 28 pce
28 KAP
View
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