Human medicines European public assessment report (EPAR): Qaialdo, spironolactone, Date of authorisation: 26/05/2023, Revision: 5, Status: Authorised

• Application under evaluation
• CHMP opinion
• European Commission decision

Overview

Qaialdo is a medicine used to manage refractory oedema (swelling due to fluid build-up that does not respond to standard treatments) associated with any of the following conditions:

• congestive heart failure (when the heart does not pump blood as well as it should and fluid builds up around the heart and in the legs);
• hepatic cirrhosis (liver scarring) with ascites (fluid build-up in the belly) and oedema (fluid build-up in the legs, feet and ankles);
• malignant ascites (ascites caused by cancer cells spreading to the organs in the belly);
• nephrotic syndrome (a group of symptoms associated with kidney damage, such as the presence of protein in the urine or oedema);
• essential hypertension (high blood pressure without a known cause).

It can also be used to diagnose and treat primary aldosteronism, a condition in which the body produces too much of the hormone aldosterone, which also results in oedema.

Qaialdo is a ‘hybrid medicine’. This means that the medicine is similar to a ‘reference medicine’ containing the same active substance, but Qaialdo is available as a liquid to be taken by mouth while the reference medicine is available as tablets. The reference medicine for Qaialdo is Aldactone.

Qaialdo contains the active substance spironolactone.

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How is Qaialdo used?

The medicine can only be obtained with a prescription, and children should only be treated under supervision of a paediatric specialist.

Qaialdo is available as a suspension (a liquid with solid particles in it) to be taken by mouth once a day.

For more information about using Qaialdo, see the package leaflet or contact your doctor or pharmacist.

How does Qaialdo work?

The active substance in Qaialdo, spironolactone, works by blocking the effects of aldosterone, a hormone that helps control water balance in the body. The medicine blocks specific receptors (targets) for aldosterone in the kidneys. This increases the elimination of salt and water in the form of urine while keeping levels of potassium from getting too low. This, in turn, reduces oedema.

What benefits of Qaialdo have been shown in studies?

Spironolactone has been used in the European Union for several decades to treat refractory oedema. As for every medicine, the company provided studies on the quality of Qaialdo. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Because Qaialdo is bioequivalent to the reference medicine, its benefits are taken as being the same as the reference medicine’s.

What are the risks associated with Qaialdo?

For the full list of side effects and restrictions with Qaialdo, see the package leaflet.

Because Qaialdo is bioequivalent to the reference medicine, its risks are taken as being the same as the reference medicine’s.

The most common side effects with Qaialdo (which may affect more than 1 in 10 people) include hyperkalaemia (high blood potassium levels, which can cause tiredness, muscle weakness, feeling sick and heart rhythm disturbances). Gynaecomastia (breast growth in men) and breast pain are seen in up to 1 in 10 males.

Why is Qaialdo authorised in the EU?

Qaialdo has been shown to be comparable to the reference medicine. Therefore, the Agency’s view was that, as for Aldactone, the benefits of Qaialdo outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Qaialdo?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Qaialdo have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Qaialdo are continuously monitored. Suspected side effects reported with Qaialdo are carefully evaluated and any necessary action taken to protect patients.

Other information about Qaialdo

Qaialdo received a marketing authorisation valid throughout the EU on 26 May 2023.

Qaialdo : EPAR - Medicine overview

Reference Number:

EMA/162307/2023

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Qaialdo : EPAR - Risk-management-plan summary

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Product information

Qaialdo: EPAR - Product information

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Latest procedure affecting product information:

VR/0000333112

24/03/2026

This medicine’s product information is available in all official EU languages. Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Qaialdo : EPAR - All authorised presentations

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Product details

Name of medicine

Qaialdo

Active substance

spironolactone

International non-proprietary name (INN) or common name

spironolactone

Therapeutic area (MeSH)

• Edema
• Heart Failure
• Liver Cirrhosis
• Ascites
• Nephrotic Syndrome
• Hyperaldosteronism
• Essential Hypertension

Anatomical therapeutic chemical (ATC) code

C03DA01

Pharmacotherapeutic group

Antihypertensives and diuretics in combination

Therapeutic 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).

Authorisation details

EMA product number

EMEA/H/C/005535

Marketing authorisation holder

Lipomed GmbH

Hegenheimer Strasse 2 79576 Weil am Rhein Germany

Marketing authorisation issued

26/05/2023

Revision

5

Assessment history

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Changes since initial authorisation of medicine

Qaialdo : EPAR - Procedural steps taken and scientific information after the authorisation

English (EN) (164.17 KB - PDF)

First published:

20/08/2025

Last updated:

24/03/2026

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Qaialdo : EPAR - Procedural steps taken and scientific information after the authorisation (archived)

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First published:

20/02/2025

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Qaialdo-H-C-PSUSA-00002780-202403 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number:

EMA/64675/2025

English (EN) (128.64 KB - PDF)

First published:

20/02/2025

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Initial marketing authorisation documents

Qaialdo : EPAR - Public assessment report

Adopted

Reference Number:

EMA/175439/2023

English (EN) (1.07 MB - PDF)

First published:

25/07/2023

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CHMP summary of positive opinion for Qaialdo

Adopted

Reference Number:

EMA/CHMP/141137/2023

English (EN) (149.93 KB - PDF)

First published:

31/03/2023

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News on Qaialdo

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023

31/03/2023

This page was last updated on

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