GAVRETO

This brand name is authorized in United States. It is also authorized in Austria, Croatia, Ecuador, Estonia, France, Ireland, Israel, Italy, Lithuania, Poland, Romania.

Active ingredients

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

1
UNII 1WPE73O1WV - PRALSETINIB
 

Pralsetinib is a potent protein kinase inhibitor that selectively targets oncogenic RET fusions (KIF5BRET and CCDC6-RET). In non-small cell lung cancer (NSCLC), RET fusions are one of the main oncogenic drivers.

 
Read more about Pralsetinib

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 GAVRETO Hard capsule MPI, EU: SmPC European Medicines Agency (EU)
 GAVRETO Capsule MPI, US: SPL/PLR FDA, National Drug Code (US)

Medicine classification

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

ATC Group Classification
L01EX23 L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EX Other protein kinase inhibitors
Discover more medicines within L01EX23

Authorization and marketing

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

Country Identification scheme Identifier(s)
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 6644-MEE-1021
EE Ravimiamet 1867765, 1867776, 1867787
FR Base de données publique des médicaments 67194402
IL מִשְׂרַד הַבְּרִיאוּת 9015, 9016, 9017
IT Agenzia del Farmaco 049771013, 049771025, 049771037
LT Valstybinė vaistų kontrolės tarnyba 1093820, 1093821, 1093822
PL Rejestru Produktów Leczniczych 100460685
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W68296001, W68296002
US FDA, National Drug Code 72064-210

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