Is Alpelisib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Alpelisib, including piqray (200 mg, Film-coated tablet, SAR 17606.34); piqray (150 mg, Film-coated tablet, SAR 17606.34); piqray 200 mg + 50 mg (250 mg, Film-coated tablet, SAR 17606.34).

Is Alpelisib approved by the US FDA?

Drugs@FDA lists 3 application product lines for Alpelisib, including PIQRAY (Prescription); VIJOICE (Prescription); VIJOICE (Prescription).

Is Alpelisib authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Alpelisib: Piqray, Vijoice.

Are there safety signals or safety updates for Alpelisib?

US FDA: 3 entries (latest 2025-07-22).

Active substance

Alpelisib

SFDA 3
US FDA 3
EMA 3
Health Canada 3
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
piqray	200 mg	Film-coated tablet · Oral use	28 Blister	SAR 17606.34	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Valid
piqray	150 mg	Film-coated tablet · Oral use	56 Blister	SAR 17606.34	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Valid
piqray 200 mg + 50 mg	250 mg	Film-coated tablet · Oral use	56 Blister	SAR 17606.34	NCE · Prescription	NOVARTIS PHARMA SCHWEIZ AG	Valid

Indications — CHI Daman Drug Formulary

BREAST CANCER MET.HER-2 -VE

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
PIQRAY	50MG; 150MG; 200MG	tablet · oral	NOVARTIS	Prescription	24 May 2019
VIJOICE	50MG; 125MG; 200MG	tablet · oral	NOVARTIS	Prescription	5 Apr 2022
VIJOICE	50MG/PACKET	granule · oral	NOVARTIS	Prescription	24 Apr 2024

EMA European Union — centrally authorised medicines

Piqray Novartis Europharm Limited · Authorised · authorised 27 Jul 2020 · ATC L01XE

Therapeutic indication (EMA)

Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following an endocrine-based regimen (see section 5.1 and for biomarker-based patient selection see section 4.2).

Vijoice Novartis Europharm Limited · Authorised · authorised 15 Jul 2026 · ATC L01EM03

Therapeutic indication (EMA)

Treatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related overgrowth spectrum (PROS)

Vijoice Novartis Europharm Limited · Application withdrawn · ATC L01EM03

Therapeutic indication (EMA)

Treatment of patients with severe manifestations of PIK3CA-related overgrowth spectrum

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PIQRAY	02497069	150 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
PIQRAY	02497077	200 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC
PIQRAY	02497085	50 MG; 200 MG	KIT; TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

US FDA 22 Jul 2025 VIJOICE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Jul 2025 VIJOICE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Jan 2024 PIQRAY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for alpelisib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.