PIQRAY

This brand name is authorized in Austria, Brazil, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States

Active ingredients

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

1 Alpelisib UNII 08W5N2C97Q - ALPELISIB

Alpelisib is an α-specific class I phosphatidylinositol3kinase (PI3Kα) inhibitor. Gain-of-function mutations in the gene encoding the catalytic α-subunit of PI3K (PIK3CA) lead to activation of PI3Kα and AKT-signalling, cellular transformation and the generation of tumours in in vitro and in vivo models. Read about Alpelisib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
PIQRAY Tablet	FDA, National Drug Code (US)	MPI, US: SPL/PLR
PIQRAY Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

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

ATC code	Group title	Classification
L01EM03		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EM Phosphatidylinositol-3-kinase (Pi3K) inhibitors
Discover more medicines within L01EM03

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 526520020094607, 526520020094707, 526520020094807, 526520020094907, 526520020095007
Country: CA	Health Products and Food Branch	Identifier(s): 02497069, 02497077, 02497085
Country: EE	Ravimiamet	Identifier(s): 1824634, 1824645, 1824656, 1824667, 1824678, 1824689, 1824690, 1824702, 1824713
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1201455002, 1201455005, 1201455008
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 099436, 432189, 462429
Country: FR	Base de données publique des médicaments	Identifier(s): 62444026, 62801026, 69009763
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 389090, 389093, 389096, 389101
Country: HK	Department of Health Drug Office	Identifier(s): 66925, 66926, 66927
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8525, 8526, 8527
Country: IT	Agenzia del Farmaco	Identifier(s): 048918015, 048918027, 048918039, 048918041, 048918054, 048918066, 048918078, 048918080, 048918092
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1090899, 1090900, 1090904, 1090905, 1090906, 1090907, 1090908, 1090909, 1090910
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 204676, 204684, 204692
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 21462, 21463, 21464
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100439052, 100439069, 100439075
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W67221001, W67222001, W67223001
Country: US	FDA, National Drug Code	Identifier(s): 0078-0701, 0078-0708