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PRODUCT DETAIL

Nilotinib Accord 50 mg tvrdé kapsuly

Code 7594E
MA number EU/1/24/1845/004
Product Form: cps dur 120(3x40x1)x50 mg (blis.PVC/PVDC/Al - jednotk.multibal.)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
MAH, country: Accord Healthcare S.L.U, Spain
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: 36
Container: blister PVC/PVDC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 22.08.2024
Validity: 22.08.2029
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 23.09.2024
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