ATC codes:
L01BC01
EMLc
Indication
Langerhans cell histiocytosis
ICD11 code:
2B31.2
INN
Cytarabine
Medicine type
Chemical agent
List type
Complementary
Formulations
Parenteral > General injections > unspecified:
100 mg in vial powder for injection ;
100 mg per mL in vial
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
Patents have expired in most jurisdictions
Read more
about patents.
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 an additional dose form of cytarabine (100 mg/mL in vial) to the EML and EMLc.