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PRODUCT DETAIL

Nilotinib Viatris 200 mg

Code 7368E
MA number 44/0225/24-S
Product Form: cps dur 112x1 (4x28x1)x200 mg (blis.OPA/Al/PVC//Al - jednotk.multibal.)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: Viatris Limited, Ireland
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: 10.09.2024
Validity: 10.09.2029
Pediatric indication: Yes
Pediatric posology: Yes
Pediatric warnings: Yes
SPC: SPC_Nilotinib Viatris 200 mg_09.2024.pdf  
PIL: PIL_Nilotinib Viatris 200 mg_09.2024.pdf  
Safety feature Yes
Data update: 11.09.2024
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