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ATC codes: V03AB14
EMLc
Indication
Haemorrhagic disorder due to other specified circulating anticoagulants ICD11 code: 3B21.Y
INN
Protamine sulfate
Medicine type
Chemical agent
List type
Core (EML)
Complementary (EMLc)
Formulations
Parenteral > General injections > IV: 10 mg per mL in 5 mL ampoule
EML status history
First added in 1977 (TRS 615)
Changed in 1979 (TRS 641)
Changed in 1984 (TRS 722)
Changed in 2007 (TRS 950)
Sex
All
Age
Also recommended for children
Therapeutic equivalence
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
Protamine sulfate was added to the complementary list of the EMLc to reverse the effect of heparin. The Subcommittee accepted that medicines affecting coagulation were essential for children and endorsed protamine sulfate for inclusion in the EMLc. Because of the need for specialist supervision of the administration of heparin sodium, protamine sulfate and warfarin in children, the Subcommittee recommended that these three medicines be included in the Complementary List.