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Idea AG’s decision to withdraw its application for a centralised marketing authorisation for the medicine Diractin (ketoprofen) 22.9mg gel has been formally notified to the European Medicines Agency (EMEA).
Diractin was expected to be used for the symptomatic treatment of inflammation and pain in osteoarthritis.
At the time of the withdrawal, it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).
The company states that the efficacy of the medicine at the proposed dose has not been sufficiently demonstrated, and that this concern has been identified as a major clinical issue.
More information about Diractin and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document.
This document, together with the withdrawal letter from the company, will be published on the EMEA website in due course.
The application for the marketing authorisation for Diractin was submitted to the EMEA on May 23 2007.
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