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ATC codes: J06BA02
EMLc
Indication
Langerhans cell histiocytosis ICD11 code: 2B31.2
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: 5% protein solution ; 10% protein solution
EML status history
First added in 2023 (TRS 1049)
Sex
All
Age
Also recommended for children
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Summary of evidence and Expert Committee recommendations
The Expert Committee recommended the current listings of cytarabine, immunoglobulin, mercaptopurine, methotrexate, prednisolone, vinblastine and vincristine on the complementary list of the EML and EMLc be extended to include the new indication of Langerhans cell histiocytosis (LCH). While LCH is considered a rare disease, the Committee acknowledged that treatment is associated with very high survival rates in many cases. These medicines are recognized as part of the standard of care for children with LCH. Their benefits and harms were accepted as being well established from use in other indications in children and in adults.