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PRODUCT DETAIL

Copiktra 15 mg tvrdé kapsuly

Code 7747D
MA number EU/1/21/1542/001
Product Form: cps dur 56 (2x28) x 15 mg (lis.PVC/PE/PCTFE/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
L01EM Phosphatidylinositol-3-kinase (Pi3K) inhibitors
L01EM04 Duvelisib
Shelf life: 48
Container: blister PVC/PE/PCTFE/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: 19.05.2021
Validity: 19.05.2026
SmPC + PL: European Medicines Agency's database
Safety feature Yes
Data update: 28.05.2021
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