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ATC codes: B02BA01
EMLc
Indication
Haemorrhagic or haematological disorders of fetus or newborn ICD11 code: KA8Z
INN
Phytomenadione
Medicine type
Chemical agent
List type
Core (EML)
(EMLc)
Formulations
Parenteral > General injections > IV: 10 mg per mL in ampoule ; 1 mg per mL in ampoule (EMLc)
EML status history
First added in 1977 (TRS 615)
Changed in 1979 (TRS 641)
Changed in 2007 (TRS 950)
Sex
All
Age
Newborn (< 1 month)
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 Subcommittee accepted that medicines affecting coagulation were essential for children and endorsed phytomenadione for inclusion in the EMLc. As phytomenadione is routinely administered to neonates, the Subcommittee decided this medicine should be included in the Core List and recommended the addition of phytomenadione injection 1 mg/ml to the list.