PIVIKTO

This brand name is authorized in Nigeria. It is also authorized in South Africa.

Active ingredients

The drug PIVIKTO 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

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A4-100496	Tablet	Pivikto 50 mg Film Coated Tablets TAB 50 mg 14's; 28's	Film Coated Tablets	31/08/2023
A4-100514	Film coated tablet	Pivikto 150 mg Film Coated Tablet TAB 150 mg 28's; 56's	Film Coated Tablet	31/08/2023
A4-100515	Tablet	Pivikto 200 mg Film Coated Tablet TAB 200 mg 14's; 28's	Film Coated Tablet	31/08/2023

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)
NG	Registered Drug Product Database	A4-100496, A4-100514, A4-100515
ZA	Health Products Regulatory Authority	55/26/0290, 55/26/0291, 55/26/0292