European Medicines Agency (EMA) adopts positive opinion for Bopediat® (furosemide) as Proveca’s third Paediatric Use Marketing Authorisation (PUMA)
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European Medicines Agency (EMA) adopts positive opinion for Bopediat® (furosemide) as Proveca’s third Paediatric Use Marketing Authorisation (PUMA)
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.”
About Oedema and Hypertension in Children and Adolescence
Oedema refers to the accumulation of excess fluid in the body’s tissues and may occur in paediatric patients from birth through to adolescence as a result of cardiac, renal or hepatic conditions. The clinical presentation and severity of oedema in children vary depending on the underlying cause and disease progression.
Hypertension in paediatric patients is defined as persistently elevated blood pressure relative to age, sex and height. Although less common than in the adult population, paediatric hypertension is well recognised and requires appropriate clinical management to reduce long-term complications.
The availability of child-appropriate formulations is an important consideration in paediatric care, as administration challenges may impact treatment outcomes in younger populations.
About Bopediat®
Bopediat® is an orodispersible tablet which contains the active pharmaceutical ingredient, furosemide (a loop diuretic). The tablet strength is 5mg and includes a functional score line, enabling accurate doses of 2.5mg. Furosemide is a widely used diuretic with a well understood safety profile; very common adverse reactions (≥1/10) include: electrolyte imbalance, dehydration, hypovolaemia, increase in serum creatinine, increase in triglycerides and orthostatic hypotension.
About Proveca
Proveca Ltd. is a UK-founded pharmaceutical company, with technical and commercial operations globally. The company specialises in the development, licensing and commercialisation of evidence-based medicines to address the unmet medical needs of children, with a current paediatric product portfolio in neurology and cardiology.
For more information about Proveca and/or this press release, please contact:
Dr Simon Bryson, CEO
Phone: +44 161 468 2627
Email: medical@proveca.com
www.proveca.com
UK-FUR-26-0001 March 2026