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PRODUCT DETAIL

Zydelig 150 mg filmom obalené tablety

Code 2193B
MA number EU/1/14/938/002
Product Form: tbl flm 60x150 mg (fľ.HDPE)
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
L01EM01 Idelalisib
Shelf life: 60
Container: bottle HDPE
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: 18.09.2014
Validity: 19.09.2024
SmPC + PL: European Medicines Agency's database
Dokument: DHCP_Zydelig (PRINT) 17 8 2016.pdf  
Dokument: DHPC Zydelig 22 3 2016.pdf  
Safety feature Yes
Data update: 14.10.2021
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