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PRODUCT DETAIL

Scemblix 40 mg filmom obalené tablety

Code 1989E
MA number EU/1/22/1670/003
Product Form: tbl flm 20x40 mg (blis.PCTFE/PVC/Al)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01E Protein kinase inhibitors
L01EA BCR-ABL tyrosine kinase inhibitors
L01EA06 Asciminib
Shelf life: 36
Container: blister PCTFE/PVC/Al
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: 25.08.2022
Validity: 25.08.2027
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 19.06.2023
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