ZYDELIG

This brand name is authorized in United States. It is also authorized in Australia, Austria, Canada, Croatia, Cyprus, Estonia, France, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Spain, UK.

Active ingredients

The drug ZYDELIG contains one active pharmaceutical ingredient (API):

1
UNII YG57I8T5M0 - IDELALISIB
 

Idelalisib inhibits phosphatidylinositol 3-kinase p110δ (PI3Kδ), which is hyperactive in B-cell malignancies and is central to multiple signalling pathways that drive proliferation, survival, homing, and retention of malignant cells in lymphoid tissues and bone marrow. Idelalisib induces apoptosis and inhibits proliferation in cell lines derived from malignant B-cells and in primary tumour cells.

 
Read more about Idelalisib

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 ZYDELIG Film-coated tablet MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
L01EM01 L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EM Phosphatidylinositol-3-kinase (Pi3K) inhibitors
Discover more medicines within L01EM01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 11162L, 11165P, 11170X, 11171Y
CA Health Products and Food Branch 02438798, 02438801
EE Ravimiamet 1664883, 1664894
ES Centro de información online de medicamentos de la AEMPS 114938001, 114938002
FR Base de données publique des médicaments 68093737, 69111017
GB Medicines & Healthcare Products Regulatory Agency 347180, 347184
IE Health Products Regulatory Authority 88299, 88333
IT Agenzia del Farmaco 043620018, 043620020
LT Valstybinė vaistų kontrolės tarnyba 1074493, 1074494
NL Z-Index G-Standaard, PRK 120103, 120111
NZ Medicines and Medical Devices Safety Authority 17527, 17529
PL Rejestru Produktów Leczniczych 100327258, 100327264
US FDA, National Drug Code 61958-1701, 61958-1702

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