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PRODUCT DETAIL

Calquence 100 mg tvrdé kapsuly

Code 5864D
MA number EU/1/20/1479/001
Product Form: cps dur 56x100 mg (blis.Al/Al)
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
L01EL Bruton`s tyrosine kinase (BTK) inhibitors
L01EL02 Acalabrutinib
Shelf life: 36
Container: blister Al/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: 05.11.2020
Validity: 05.11.2025
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 14.12.2021
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