NILOTINIB Zentiva caps 50 mg 120 pce

7680698460015 CH-69846 L01EA03 07.16.1.

Active substances:

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Details

Product number
6984601
CPT
-
Packaging group
120
Unit
Kapsel(n)
Composition
nilotinibum 50 mg, lactosum monohydricum 43.45 mg, crospovidonum, polysorbatum 80, magnesii aluminometasilicas, magnesii stearas, silica colloidalis anhydrica, Kapselhülle: gelatina, E 171, E 172 (rubrum), E 172 (flavum), aqua purificata, Drucktinte: lacca, E 172 (nigrum), kalii hydroxidum, pro capsula.

Articles (1)

Nilotinib Zentiva 50 mg, Hartkapseln
Kapseln
120
View

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
01/04/2026
Patient information leaflet
Français
01/04/2026
Patient information leaflet
Italien
01/04/2026
Professional SmPC
Allemand
01/04/2026
Professional SmPC
Français
01/04/2026
Professional SmPC
Italien
01/04/2026

Detailed composition

Substance Quantity Type Category
nilotinibum
50.0 MG Substance Wirkstoff (Principe actif)
lactosum monohydricum
43.45 MG Substance HBESI
crospovidonum
- Substance HNIDK
polysorbatum 80
- Substance HNIDK
magnesii aluminometasilicas
- Substance HNIDK
magnesii stearas
- Substance HNIDK
silica colloidalis anhydrica
- Substance HNIDK
gelatina
- Substance HNIDK
E 171
- Substance FNIDK
E 172 (rubrum)
- Substance FTODK
E 172 (flavum)
- Substance FTODK
aqua purificata
- Substance HNIDK
lacca
- Substance HNIDK
E 172 (nigrum)
- Substance FTODK
kalii hydroxidum
- Substance HNIDK

Authorization holder

Helvepharm AG

8500 Frauenfeld

Authorization information

Swissmedic authorization number
69846
Drug name
Nilotinib Zentiva, Hartkapseln
Galenic form
KAHA
ATC Code
L01EA03
Authorization status
Z
Dispensation category
A
First authorization
20/11/2025
Authorization expiration date
19/11/2030
IT number
07.16.1.
Domain
Human medicine
Field of application
Onkologikum, Tyrosin-Kinase-Hemmer zur Behandlung der chronischen myeloischen Leukämie

Packaging details

Description (FR)
NILOTINIB Zentiva caps 50 mg 120 pce
Description (DE)
NILOTINIB Zentiva Kaps 50 mg 120 Stk
Market launch
01/04/2026
Narcotic (BTM)
No

Available generics

Nilotinib Accord, Hartkapseln
CHF 1036.95
View
Nilotinib Accord, Hartkapseln
CHF 484.75
View
Nilotinib Accord, Hartkapseln
CHF 1552.60
View
Nilotinib Zentiva, Hartkapseln
CHF 1018.20
View
Nilotinib Zentiva, Hartkapseln
CHF 483.60
View
Nilotinib Zentiva, Hartkapseln
CHF 1552.20
View

Other packaging sizes

NILOTINIB Zentiva caps 150 mg 112 pce
112 KAP
View
NILOTINIB Zentiva caps 200 mg 28 pce
28 KAP
View
NILOTINIB Zentiva caps 200 mg 112 pce
112 KAP
View
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