Regulatory PathRegulatory requirements compared

Active substance

Nonacog gamma

Open in the medicines table

EMA European Union — centrally authorised medicines

Rixubis Baxalta Innovations GmbH · Authorised · authorised 19 Dec 2014 · ATC B02BD04

Therapeutic indication (EMA)

Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
RIXUBIS024319471000 UNIT / VIALKIT; POWDER FOR SOLUTION · INTRAVENOUSTAKEDA CANADA INC
RIXUBIS024319552000 UNIT / VIALKIT; POWDER FOR SOLUTION · INTRAVENOUSTAKEDA CANADA INC
RIXUBIS024319633000 UNIT / VIALPOWDER FOR SOLUTION; KIT · INTRAVENOUSTAKEDA CANADA INC

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.