Penthrox Marketing Authorisation Application in Russia
6 December 2019
ASX ANNOUNCEMENT
Penthrox Marketing Authorisation Application in Russia
Medical Developments International Limited (ASX: MVP) announced today that the Russian Ministry of Health has accepted MVP’s Marketing Authorisation Application (MAA) for review. MVP submitted the MAA for Penthrox on 30 September and after a two-month validation period, the Russian Ministry of Health advised that the Penthrox MAA had been accepted.
At this stage MVP has been advised that no further clinical work is required in Russia and that the Ministry of Health intend to review the same “Clinical, Safety and Efficacy” data, which MVP used to support the approval of Penthrox in Europe and elsewhere.
MVP’s application to the Ministry of Health is for Penthrox to be approved for Trauma Pain.
For further details please click on the following link – ASX Announcement – Russia accepts Penthrox MAA