PIQRAY

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

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 more about Alpelisib

Medication package inserts

Below package inserts are available for further reading:

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