Vijoice

alpelisib · Novartis Europharm Limited
ORPHAN CONDITIONAL APPROVAL AUTHORISED IN THE EU

What Vijoice is used for

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

Approved use, as published by the European Medicines Agency.

What the labels mean

  • Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
  • Conditional approval: approved on less complete data because the need is high; more data must follow.

Key facts

Brand
Vijoice
Active substance
alpelisib
Disease area
Genetic Diseases, Inborn; Growth Disorders
Medicine group
Antineoplastic agents
ATC code
L01EM03
Marketing authorisation holder
Novartis Europharm Limited
Authorised in the EU since
2026

Official information

In the USA

Same active substance: Vijoice, Piqray

In India

Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.

Common questions

What is Vijoice used for?

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

What is the active substance in Vijoice?

Vijoice contains alpelisib.

Who makes Vijoice?

The EU marketing authorisation holder is Novartis Europharm Limited.

Is Vijoice an orphan medicine?

Yes. Vijoice is designated an orphan medicine in the EU, for a rare disease (Genetic Diseases, Inborn; Growth Disorders).

Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.

← All specialty medicines, EU

For information only, not medical advice. This page is a plain-language summary written from standard prescribing information and the public guides linked below. Brands sometimes change their formula, so always check the composition printed on the pack. Doses here are typical adult doses; yours may differ. Do not start, stop or change a medicine without your doctor or pharmacist, and keep all medicines away from children. In an emergency, call 112 (India) or your local emergency number.