Jivi Bayer AG · Authorised · authorised 22 Nov 2018 · ATC B02BD02
Therapeutic indication (EMA)
Treatment and prophylaxis of bleeding in previously treated patients (PTPs) ≥ 7 years of age with haemophilia A (congenital factor VIII deficiency).
Active substance
Damoctocog alfa pegol
- EMA 1
- UK MHRA 5
EMA European Union — centrally authorised medicines
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| JIVI 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PLGB 00010/0682 | BAYER PLC | POM |
| JIVI 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PLGB 00010/0683 | BAYER PLC | POM |
| JIVI 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PLGB 00010/0684 | BAYER PLC | POM |
| JIVI 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PLGB 00010/0685 | BAYER PLC | POM |
| JIVI 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PLGB 00010/0686 | BAYER PLC | POM |
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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.