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Calcitriol
The Expert Committee, after evaluation, declines to list the medicine proposed in the application.
The Model List of Essential Medicines reports reasons that Committee Members have identified for denying listing.
Rejected
Section:
18. Medicines for endocrine disorders
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Rejected
ATC codes: A11CC04
Indication
Chronic kidney disease, stage unspecified ICD11 code: GB61.Z
INN
Calcitriol
Medicine type
Chemical agent
List type
Complementary
Formulations
Oral > Solid > capsule: 0.25 µg ; 0.5 µg
EML status history
Application rejected in 2023 (TRS 1049)
Sex
All
Age
Adolescents and adults
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Wikipedia
Calcitriol
DrugBank
Calcitriol
Summary of evidence and Expert Committee recommendations
The Expert Committee did not recommend inclusion of the vitamin D analogues alfacalcidol and calcitriol on the complementary list of the EML and EMLc, for the proposed indications of hypoparathyroidism, hypophosphataemic rickets, hypocalcaemic vitamin D dependent/resistant rickets, neonatal hypocalcaemia, chronic kidney disease, and other disorders of vitamin D metabolism or transport at this time. While the application included reference to conditional guideline recommendations for the use of vitamin D analogues in chronic kidney disease, hypophosphataemic rickets and hypoparathyroidism, overall, the Committee noted that evidence base was uncertain due to risk of bias, indirectness when assessing patient-important outcomes, inconsistencies, and imprecision. The Committee considered that the limited likelihood of influencing important clinical outcomes was potentially outweighed by the risks associated with the use of alfacalcidol and calcitriol, such as hypercalciuria, decrease in renal function and cardiovascular risk.