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Rejected
ATC codes:
M05BA08
EMLc
Indication
Osteogenesis imperfecta
ICD11 code:
LD24.K0
INN
Zoledronic acid
Medicine type
Chemical agent
List type
Complementary
Formulations
Parenteral > General injections > IV:
4 mg per 5 mL in 5 mL vial ;
4 mg per 100 mL in 100 mL bottle
EML status history
Application rejected 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.
Wikipedia
DrugBank
Summary of evidence and Expert Committee recommendations
The Expert Committee did not recommend inclusion of zoledronic acid on the EML and EMLc for the new indication of osteogenesis imperfecta. The Committee noted that available evidence suggests that bisphosphonates may increase bone mineral density but considered that the benefits of bisphosphonate treatment on other important outcomes such as fracture risk, bone pain and physical functioning were unclear.