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News

Penthrox Regulatory Approval in UK and Europe

May 6, 2015Cathy WilsonNews

6 May 2015

ASX Announcement

Penthrox successfully completes its Decentralised Regulatory Approval Procedure in Europe

Medical Developments International Limited (ASX: MVP) is delighted to announce that the Medicine and Healthcare products Regulatory Agency (MHRA) has issued the Final Assessment Report with the support of France, Belgium and Ireland authorities noting all outstanding issues pursuant to the Decentralised Procedure have been successfully resolved and Penthrox is approvable.

MVP now moves into the National Phase which is a purely administrative process whereby each of the countries approve the translation of the labelling and product information, and registers Penthrox as being available for sale in their national records. The National Phase should take 30 days and thereafter Marketing Authorisation will be issued and Penthrox will be available for sale in these markets.

For more information click on the following link ASX Announcement – Regulatory Approval in UK and Europe

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Medical Developments International

Address:
4 Caribbean Drive, Scoresby,
Victoria, 3179
Australia
Phone: +61 3 9547 1888
Email: [email protected]
ABN: 14 106 340 667
For Medical Enquiries:

Phone: 1800 PENTHROX (1800 736 847)
Email: [email protected]

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