ATC codes: G03XB51
Unspecified time of fetal death, cause not specified ICD11 code: KD3B.Z
Mifepristone + misoprostol
Medicine type
Chemical agent
List type
Additional notes
Where permitted under national law and where culturally acceptable.
Oral > Solid: 200 mg + 200 µg ; 200 mg [1] + 200 µg [4] in co-package
EML status history
First added in 2023 (TRS 1049)
Adolescents and adults
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 Committee recommended that the current listing of mifepristone + misoprostol on the core list of the EML be extended to include the new indication of medical management of intra-uterine fetal demise. The Committee noted evidence that the combination regimen was associated with higher rates of expulsion and shorter expulsion times than misoprostol alone. The Committee considered that adverse effects associated with use of the combination were generally mild, well-known and manageable. The Committee also noted that the medical management of intra-uterine fetal demise using this combination regimen has been included in WHO guidelines for medical management of abortion since 2018.