ATC codes: L01BA01
Langerhans cell histiocytosis ICD11 code: 2B31.2
Medicine type
Chemical agent
List type
Complementary (EML)
Parenteral > General injections > IV: 50 mg in vial (as sodium salt) ; 50 mg per 2 mL ; 1000 mg per 10 mL concentrated injection
Oral > Solid: 2.5 mg (as sodium salt)
EML status history
First added in 2023 (TRS 1049)
Also recommended for children
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
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. Following the review of the age-appropriateness of formulations on the EMLc, the Expert Committee recommended the inclusion of additional dose forms of methotrexate (Injection: 50 mg/2 mL and Concentrated injection: 1000 mg/10 mL) to the EML and EMLc.