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ATC codes: B02BD01
EMLc
Indication
Haemophilia B ICD11 code: 3B11.0
Medicine type
Biological agent
List type
Complementary All human plasma-derived medicines should comply with the WHO requirements.
Formulations
Parenteral > General injections > IV: 500 IU in vial powder for injection ; 1000 IU in vial powder for injection
EML status history
First added in 1979 (TRS 641)
Changed in 1989 (TRS 796)
Changed in 2007 (TRS 950)
Changed in 2013 (TRS 985)
Sex
All
Age
Also recommended for children
Therapeutic equivalence
The recommendation is for this specific medicine
Patent information
Summary of evidence and Expert Committee recommendations
The Expert Committee decided to change the heading of Section 11 to “Blood products of human origin and plasma substitutes” and to restructure the section to specify blood products clearly. The note under Subsection 11.2 would be moved to Subsection 11.1 and would be updated to reflect World Health Assembly resolution WHA63.12. Subsection 11.1 would be re-labelled “Blood and blood components” and would list fresh–frozen plasma, red blood cells, platelets and whole blood. The balance of the section would be renumbered. Subsection 11.2 would be labelled “Plasma-derived medicinal products”, with a Subsection 11.2.1 labelled “Human immunoglobulins”. Subsection 11.2.2 would be labelled “Blood coagulation factors” and would list factor VIII and factor IX. Subsection 11.3 would be labelled “Plasma substitutes”.