Bopediat (furosemide)
- Region
- 🇪🇺 EU
- Active substance
- furosemide
- Company
- Proveca Pharma Limited
- Status
- Authorised
- Therapeutic area
- Edema, Cardiac; Edema; Hypertension; Renal Insufficiency, Chronic
- CHMP opinion
- Thu 26 Mar 2026
- EU approval
- Fri 29 May 2026
- Application
- EMEA/H/C/006617
- ATC
- C03CA01
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
Fri 29 May 2026🇪🇺 EU approval (EC decision)
Bopediat (furosemide) approved in the EU
Marketing authorisation to Proveca Pharma Limited · source
Thu 26 Mar 2026🇪🇺 CHMP positive opinion
Bopediat (furosemide): CHMP positive opinion
Same substance in other markets
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.