Regulatory PathRegulatory requirements compared

Active substance

Velaglucerase alfa

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
VPRIV 40 U POWDER FOR SOLUTION FOR INFUSION400 UPowder for solution for infusion · Intravenous use1 VialSAR 6118.55NCE · PrescriptionTakeda Pharmaceuticals International AGValid
Indications — CHI Daman Drug Formulary

GAUCHER DISEASE

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

ProductStrengthForm · routeApplicantStatusFirst approved
VPRIV400 UNITS/VIALinjectable · intravenousSHIRE HUMAN GENETICPrescription26 Feb 2010
VPRIV200 UNITS/VIALpowder · intravenousSHIRE HUMAN GENETICDiscontinued26 Feb 2010

EMA European Union — centrally authorised medicines

Vpriv Takeda Pharmaceuticals International AG Ireland Branch · Authorised · authorised 26 Aug 2010 · ATC A16AB10

Therapeutic indication (EMA)

Vpriv is indicated for long-term enzyme-replacement therapy (ERT) in patients with type-1 Gaucher disease.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
VPRIV02357119400 UNIT / VIALPOWDER FOR SOLUTION · INTRAVENOUSTAKEDA CANADA INC

Safety signals and safety-related labeling changes

  • US FDA 10 Jul 2024 VPRIV — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for velaglucerase alfa →

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.