HPRA Approves Extension of Penthrox Use for Children Aged 6 and Older, Expanding Its Market Reach
Reuters
Aug 21, 2025
HPRA Approves Extension of Penthrox Use for Children Aged 6 and Older, Expanding Its Market Reach
Medical Developments International Limited (ASX: MVP) has announced that the Health Products Regulatory Agency $(HPRA.UK)$ has approved the extension of the indication for Penthrox to include children aged 6 years and older, expanding from the prior indication of 18 years and older. This approval by HPRA, serving as the Reference Member State for the EU Decentralised Procedure $(DCP)$, permits national regulatory approval by member states, including Ireland, France, the UK, and several others. The approval also necessitates a device approval due to Penthrox being a combination product. Regulatory approvals across member states are anticipated within the next 12 months. This development follows the successful MAGPIE paediatric trial and is expected to broaden the market for Penthrox, addressing prior entry barriers in select UK ambulance trusts.
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