SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
| NovoThirteen (rFXIII) powder and solvent for solution for injection | 2500 IU | Powder and solvent for solution for injection · Intravenous use | 1 Vial | SAR 83063.45 | NCE · Prescription | NOVO NORDISK | Valid |
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)
| Brand | DIN | Strength | Form · route | Company |
| TRETTEN | 02389975 | 2500 UNIT / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | NOVO 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.