Qaialdo (spironolactone)
- Region
- 🇪🇺 EU
- Active substance
- spironolactone
- Company
- Lipomed GmbH
- Status
- Authorised
- Therapeutic area
- Edema; Heart Failure; Liver Cirrhosis; Ascites; Nephrotic Syndrome; Hyperaldosteronism; Essential Hypertension
- EU approval
- Fri 26 May 2023
- Application
- EMEA/H/C/005535
- ATC
- C03DA01
- Official record
- www.ema.europa.eu
Indication
In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. Neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2).
Regulatory milestones
No milestones recorded in the last year.
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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.