Regulatory PathRegulatory requirements compared

Active substance

Catridecacog

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
NovoThirteen (rFXIII) powder and solvent for solution for injection2500 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 83063.45NCE · PrescriptionNOVO NORDISKValid
Indications — CHI Daman Drug Formulary

CONGENITAL FACTOR XIII A-SUBUNIT DEFICIENCY

EMA European Union — centrally authorised medicines

NovoThirteen Novo Nordisk A/S · Authorised · authorised 3 Sep 2012 · ATC B02BD11

Therapeutic indication (EMA)

Long-term prophylactic treatment of bleeding in adult and paediatric patients 6 years and above with congenital factor-XIII-A-subunit deficiency.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
TRETTEN023899752500 UNIT / VIALPOWDER FOR SOLUTION · INTRAVENOUSNOVO NORDISK 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.