Pharmaceutical

Theratechnologies (TSX:TH) announced that the Paediatric Committee of the European Medicines Agency has accepted to defer the initiation of the Paediatric Investigation Plan for Trogarzo after the application for marketing authorization in Europe for Trogarzo has been filed with the EMA. As quoted in the press release: European Union regulations state that paediatric investigation plans …

Theratechnologies (TSX:TH) announced that the Paediatric Committee of the European Medicines Agency has accepted to defer the initiation of the Paediatric Investigation Plan for Trogarzo after the application for marketing authorization in Europe for Trogarzo has been filed with the EMA.

As quoted in the press release:

European Union regulations state that paediatric investigation plans should normally be conducted prior to an application for marketing authorization being filed for a medicinal product for human use. Notwithstanding, those regulations also provide for deferrals to avoid delaying access to other patient populations.

Given the deferral granted by the EMA, Theratechnologies can now focus on finalizing the application for marketing authorization for Trogarzo™ in Europe.

“Europe represents a significant market for Trogarzo™. We want to be in a position to launch it as quickly as we can. Obtaining a deferral for the paediatric investigation plan represents another major step towards meeting that objective,” said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc.

Click here to read the full press release.

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