Active substance
Antihemophilic factor
- Health Canada 9
- Safety 6
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| JIVI | 02481766 | 500 UNIT / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | BAYER INC |
| JIVI | 02481774 | 1000 UNIT / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | BAYER INC |
| JIVI | 02481782 | 2000 UNIT / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | BAYER INC |
| JIVI | 02481790 | 3000 UNIT / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | BAYER INC |
| KOVALTRY | 02451441 | 250 UNIT / VIAL | KIT; POWDER FOR SOLUTION · INTRAVENOUS | BAYER INC |
| KOVALTRY | 02451468 | 500 UNIT / VIAL | KIT; POWDER FOR SOLUTION · INTRAVENOUS | BAYER INC |
| KOVALTRY | 02451476 | 1000 UNIT / VIAL | POWDER FOR SOLUTION; KIT · INTRAVENOUS | BAYER INC |
| KOVALTRY | 02451484 | 2000 UNIT / VIAL | POWDER FOR SOLUTION; KIT · INTRAVENOUS | BAYER INC |
| KOVALTRY | 02451492 | 3000 UNIT / VIAL | KIT; POWDER FOR SOLUTION · INTRAVENOUS | BAYER INC |
Safety signals and safety-related labeling changes
- EMA PRAC 14 Apr 2016 PRAC signal: Inhibitor development in previously untreated patients
Action for MAH: update of the product information: No - EMA PRAC 17 Mar 2016 PRAC signal: Inhibitor development in previously untreated patients
Action for MAH: update of the product information: No - EMA PRAC 14 Jan 2016 PRAC signal: Inhibitor development in previously untreated patients
Action for MAH: update of the product information: No - EMA PRAC 7 May 2015 PRAC signal: Inhibitor development in previously untreated patients
Action for MAH: update of the product information: No - EMA PRAC 12 Mar 2015 PRAC signal: Inhibitor development in previously untreated patients
Action for MAH: update of the product information: No - EMA PRAC 9 Jan 2015 PRAC signal: Inhibitor development in previously untreated patients
Action for MAH: update of the product information: No
Combinations containing Antihemophilic factor
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.