7 October 2019 - Vivus announced today that European regulatory agencies in Sweden, Denmark, Finland, Iceland, Norway, and Poland have accepted the marketing authorisation application for Qsymia (phentermine and topiramate extended-release) on a decentralised basis, with Sweden acting as the lead Concerned Member State, also known as the Reference Member State, for purposes of assessing the application. 

Under the decentralised  marketing authorisation application (MAA) procedure, the regulatory authorities in each of the Concerned Member States may simultaneously provide marketing authorisation for use of a product within those specific countries.

Based on the decentralised MAA procedure timelines, the Company anticipates the completion of the MAA assessment and, if approved, marketing authorisations to begin in the second half of 2020.

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