MedPath
EMA Approval

Qaialdo

C03DA01

spironolactone

Antihypertensives and diuretics in combination

spironolactone

EdemaHeart FailureLiver CirrhosisAscitesNephrotic SyndromeHyperaldosteronismEssential Hypertension

Basic Information

EMA regulatory identification and product classification information

EMA Identifiers

ATC CodeC03DA01
EMA European Classification

Overview Summary

Comprehensive product overview and regulatory summary

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.

Authorisations (1)

EMEA/H/C/005535

Nova Laboratories Ireland Limited,3rd Floor, Ulysses House,Foley Street,Dublin 1, D01 W2T2,Ireland

Authorised

May 26, 2023

Active Substances (1)

spironolactone

Documents (8)

Qaialdo : EPAR - Public assessment report

July 25, 2023

CHANGES_SINCE_INITIAL_AUTHORISATION

Qaialdo : EPAR - Medicine overview

July 25, 2023

OVERVIEW_DOCUMENT

Qaialdo: EPAR - Product information

July 25, 2023

DRUG_PRODUCT_INFORMATION

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

February 20, 2025

CHANGES_SINCE_INITIAL_AUTHORISATION

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

February 20, 2025

CHANGES_SINCE_INITIAL_AUTHORISATION

Qaialdo : EPAR - All authorised presentations

July 25, 2023

AUTHORISED_PRESENTATIONS

CHMP summary of positive opinion for Qaialdo

March 31, 2023

CHANGES_SINCE_INITIAL_AUTHORISATION

Qaialdo : EPAR - Risk-management-plan summary

July 25, 2023

RISK_MANAGEMENT_PLAN_SUMMARY

Overview Q&A (7)

Question

How is Qaialdo used?

Answer

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.

Question

How does Qaialdo work?

Answer

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.

Question

What benefits of Qaialdo have been shown in studies?

Answer

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.

Question

What are the risks associated with Qaialdo?

Answer

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.

Question

Why is Qaialdo authorised in the EU?

Answer

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.

Question

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

Answer

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.

Question

Other information about Qaialdo

Answer

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Qaialdo - EMA Approval | MedPath