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PRODUCT DETAIL

Bosulif 400 mg filmom obalené tablety

Code 8107C
MA number EU/1/13/818/007
Product Form: tbl flm 30x400 mg (blis.PVC/PCTFE/PVC)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01E Protein kinase inhibitors
L01EA BCR-ABL tyrosine kinase inhibitors
L01EA04 Bosutinib
Shelf life: 48
Container: blister PVC/Aclar
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 27.03.2013
Validity: 07.04.2027
SmPC + PL: European Medicines Agency's database
Dokument: DHPC letter_BCR-ABLTKIs_SK 11 4 2016.pdf  
Safety feature Yes
Data update: 24.10.2022
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