Regulatory PathRegulatory requirements compared

Active substance

Velmanase alfa

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Lamzede10 mgPowder for solution for infusion · Intravenous use1 VialSAR 4352.35Biological · PrescriptionCHIESI FARMACEUTICISValid

EMA European Union — centrally authorised medicines

Lamzede Chiesi Farmaceutici S.p.A. · Authorised · authorised 23 Mar 2018 · ATC A16AB15

Therapeutic indication (EMA)

Treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.

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.