European Medicines Agency adopts positive opinion for Bopediat® (furosemide) as Proveca’s third Paediatric Use Marketing Authorisation

This press release is intended for investors only

Proveca Ltd. is delighted to announce that on the 26th of March 2026, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a Paediatric Use Marketing Authorisation (PUMA) for Bopediat® (furosemide) orodispersible tablets, a prescription only medicine (licence pending).

Bopediat® is indicated in children from birth to less than 18 years of age for the treatment of oedema of cardiac or renal origin, oedema of hepatic origin, and hypertension in patients with chronic kidney disease.

The EMA CHMP opinion is a recommendation to the European Commission (EC), which is responsible for the final decision on the marketing authorisation. A decision from the EC is anticipated by early June 2026.

Dr Simon Bryson, CEO, Proveca – “Subject to EC approval, the Bopediat® PUMA will mark Proveca’s third PUMA and the second product within our cardiovascular portfolio, further enhancing the availability of paediatric-specific medicines for children with cardiac disorders. I am proud of the Proveca team’s work over the years, with contribution to five of the ten PUMAs granted to date, reflecting the calibre of the team and the company’s paediatric leadership and continued commitment to developing and licensing medicines for children.”

Dr Helen Shaw, Co-Founder, Proveca – “Medication adherence can be particularly challenging for many young children, especially those who are chronically ill. Bopediat provides a lower-strength furosemide formulation and is an orodispersible tablet which has been designed to support administration in children.”