Nilotinib Spirig HC 150 mg, Hartkapseln

7680697710029 CH-69771 L01X 07.16.1.
Nilotinib Spirig HC 150 mg, Hartkapseln
Nilotinib Spirig HC 150 mg, Hartkapseln
Nilotinib Spirig HC 150 mg, Hartkapseln
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Details

Product number
6977102
CPT
-
Packaging group
112
Unit
Kapsel(n)
Composition
nilotinibum 150 mg ut nilotinibi hydrochloridum dihydricum, lactosum monohydricum 109.97 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 150 mg, Hartkapseln
Kapseln
112
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)
150.0 MG Substance Wirkstoff (Principe actif)
(N/A)
- Substance WIZUS
(N/A)
109.97 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

Reimbursement information

Public price
CHF 1036.95
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 150 mg 112 pce
Description (DE)
NILOTINIB Spirig HC Kaps 150 mg 112 Stk
Market launch
15/10/2025
Narcotic (BTM)
No

Other packaging sizes

NILOTINIB Spirig HC caps 50 mg 120 pce
120 KAP
GTIN: 7680697710012
View
NILOTINIB Spirig HC caps 200 mg 28 pce
28 KAP
GTIN: 7680697710036
View