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Trientine Waymade
Published
Product name
Trientine Waymade
Active ingredient
Trientine dihydrochloride
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Trientine Waymade (trientine dihydrochloride) was approved for the following therapeutic use:
Trientine Waymade is indicated in the treatment of patients with Wilson's disease who areintolerant of penicillamine.
How this medicine works
Trientine has a structure similar to polyamines and chelates copper by forming a stable complex with the four constituent nitrogens in a planar ring. The pharmacodynamic action of trientine is dependent on its property of chelating copper and elimination of the trientine copper complex in the urine. Trientine may also chelate copper in the intestinal tract and in the process inhibit copper absorption.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Trientine Waymade was considered favourable for the therapeutic use approved.
Sponsor