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PRODUCT DETAIL

Nilotinib Zentiva 200 mg

Code 6864E
MA number 44/0179/24-S
Product Form: cps dur 28x200 mg (blis.PVC/PE/PVdC//Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: Zentiva, k.s., Czechia
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01E Protein kinase inhibitors
L01EA BCR-ABL tyrosine kinase inhibitors
L01EA03 Nilotinib
Shelf life: 24
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 22.07.2024
Validity: 22.07.2029
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
PIL: PIL_Nilotinib Zentiva_07_2024.pdf  
SPC: SPC_Nilotinib Zentiva_07_2024.pdf  
Safety feature Yes
Data update: 13.08.2024
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