ATC codes: B02BD04
Haemophilia B ICD11 code: 3B11.0
All human plasma-derived medicines should comply with the WHO requirements.
Parenteral > General injections > IV: 500 IU in vial powder for injection ; 1000 IU in vial powder for injection
EML status history
Also recommended for children
Read more about patents.
Summary of evidence and Expert Committee recommendations
The Expert Committee did not recommend inclusion of recombinant coagulation factors or bypassing agents as therapeutic alternatives to plasma-derived coagulation factors under the square box listings for coagulation factors VIII and/or IX on the EML and EMLc at this time. The Committee advised that future consideration for the inclusion of these products on the Model Lists will require full applications, compliant with the requirements for EML applications and containing all relevant information, so that the available evidence can be evaluated in line with standard procedures. The Committee recommended that the square box be removed from the current listing of coagulation factor VIII, noting that other proposed alternatives (desmopressin and cryoprecipitate) are included in the Model Lists as independent listings. The Committee recommended the inclusion of additional strength formulations (250 IU and 1000 IU per vial) of factor VIII, acknowledging that these are the most commonly used and available formulations. The Committee agreed that coagulation factor IX complex is a suitable therapeutic alternative to coagulation factor IX in situations where purified factor IX is not available. The Committee therefore recommended that coagulation factor IX complex be included as a therapeutic alternative under the current square box listing for factor IX. The Committee did not recommend removal of dextran from the Model Lists. While it is not used in the treatment of haemophilia, it remains an essential plasma substitute for patients in need of blood volume replacement.