🇪🇺 Spironolactone (drug) in European Union

EMA authorised Spironolactone (drug) on 26 May 2023

Marketing authorisation

EMA — authorised 26 May 2023

  • Application: EMEA/H/C/005535
  • Marketing authorisation holder: Lipomed GmbH
  • Local brand name: Qaialdo
  • 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).
  • Status: approved

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Other Cardiovascular approved in European Union

Frequently asked questions

Is Spironolactone (drug) approved in European Union?

Yes. EMA authorised it on 26 May 2023.

Who is the marketing authorisation holder for Spironolactone (drug) in European Union?

Lipomed GmbH holds the EU marketing authorisation.