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ATC codes: B02BD01
EMLc
Indication
Haemophilia B ICD11 code: 3B11.0
Medicine type
Biological agent
List type
Complementary
Additional notes
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)
Changed in 2021 (TRS 1035)
Sex
All
Age
Also recommended for children
Therapeutic alternatives
Medicines within the same pharmacological class can be used
Therapeutic alternatives limitations
Therapeutic alternatives to be reviewed (2023)
Therapeutic alternatives limitations for EMLc
Therapeutic alternatives to be reviewed (2023)
Patent information
Summary of evidence and Expert Committee recommendations
Following the review of square box listings on the EML and EMLc, the Expert Committee recommended the therapeutic alternatives for coagulation factors be reviewed.