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

Qaialdo RSS Authorised This medicine is authorised for use in the European Union spironolactone Medicine Human 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. Expand section Collapse section 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 English (EN) (130.7 KB - PDF) First published: 25/07/2023 View Other languages (22) български (BG) (153.73 KB - PDF) First published: 25/07/2023 View español (ES) (131.4 KB - PDF) First published: 25/07/2023 View čeština (CS) (152.42 KB - PDF) First published: 25/07/2023 View dansk (DA) (130.22 KB - PDF) First published: 25/07/2023 View Deutsch (DE) (135.05 KB - PDF) First published: 25/07/2023 View eesti keel (ET) (138.15 KB - PDF) First published: 25/07/2023 View ελληνικά (EL) (153.55 KB - PDF) First published: 25/07/2023 View français (FR) (132.64 KB - PDF) First published: 25/07/2023 View hrvatski (HR) (150.07 KB - PDF) First published: 25/07/2023 View italiano (IT) (130.29 KB - PDF) First published: 25/07/2023 View latviešu valoda (LV) (166.55 KB - PDF) First published: 25/07/2023 View lietuvių kalba (LT) (149.97 KB - PDF) First published: 25/07/2023 View magyar (HU) (150.61 KB - PDF) First published: 25/07/2023 View Malti (MT) (161.02 KB - PDF) First published: 25/07/2023 View Nederlands (NL) (132.04 KB - PDF) First published: 25/07/2023 View polski (PL) (154.33 KB - PDF) First published: 25/07/2023 View português (PT) (132.05 KB - PDF) First published: 25/07/2023 View română (RO) (148.95 KB - PDF) First published: 25/07/2023 View slovenčina (SK) (151.81 KB - PDF) First published: 25/07/2023 View slovenščina (SL) (148.93 KB - PDF) First published: 25/07/2023 View Suomi (FI) (127.92 KB - PDF) First published: 25/07/2023 View svenska (SV) (128.81 KB - PDF) First published: 25/07/2023 View Qaialdo : EPAR - Risk-management-plan summary English (EN) (101.81 KB - PDF) First published: 25/07/2023 View Product information Qaialdo: EPAR - Product information English (EN) (254.92 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View Other languages (24) български (BG) (387.3 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View español (ES) (258.01 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View čeština (CS) (364.82 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View dansk (DA) (251.11 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View Deutsch (DE) (269.73 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View eesti keel (ET) (251.91 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View ελληνικά (EL) (402.89 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View français (FR) (457.02 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View hrvatski (HR) (509.19 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View íslenska (IS) (441.38 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View italiano (IT) (441.91 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View latviešu valoda (LV) (505.02 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View lietuvių kalba (LT) (522.2 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View magyar (HU) (519.64 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View Malti (MT) (541.04 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View Nederlands (NL) (257.44 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View norsk (NO) (244.6 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View polski (PL) (365.41 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View português (PT) (257.4 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View română (RO) (374.18 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View slovenčina (SK) (356.86 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View slovenščina (SL) (511.96 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View Suomi (FI) (254.61 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View svenska (SV) (251.13 KB - PDF) First published: 25/07/2023 Last updated: 24/03/2026 View 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 English (EN) (50.57 KB - PDF) First published: 25/07/2023 View Other languages (24) български (BG) (60.93 KB - PDF) First published: 25/07/2023 View español (ES) (49.33 KB - PDF) First published: 25/07/2023 View čeština (CS) (58.38 KB - PDF) First published: 25/07/2023 View dansk (DA) (50.31 KB - PDF) First published: 25/07/2023 View Deutsch (DE) (51.35 KB - PDF) First published: 25/07/2023 View eesti keel (ET) (48.38 KB - PDF) First published: 25/07/2023 View ελληνικά (EL) (64.22 KB - PDF) First published: 25/07/2023 View français (FR) (49.6 KB - PDF) First published: 25/07/2023 View hrvatski (HR) (67.26 KB - PDF) First published: 25/07/2023 View íslenska (IS) (41.8 KB - PDF) First published: 25/07/2023 View italiano (IT) (48.48 KB - PDF) First published: 25/07/2023 View latviešu valoda (LV) (67.1 KB - PDF) First published: 25/07/2023 View lietuvių kalba (LT) (67.33 KB - PDF) First published: 25/07/2023 View magyar (HU) (67.85 KB - PDF) First published: 25/07/2023 View Malti (MT) (70 KB - PDF) First published: 25/07/2023 View Nederlands (NL) (48.57 KB - PDF) First published: 25/07/2023 View norsk (NO) (41.17 KB - PDF) First published: 25/07/2023 View polski (PL) (66.55 KB - PDF) First published: 25/07/2023 View português (PT) (49.62 KB - PDF) First published: 25/07/2023 View română (RO) (66.23 KB - PDF) First published: 25/07/2023 View slovenčina (SK) (66.73 KB - PDF) First published: 25/07/2023 View slovenščina (SL) (65.42 KB - PDF) First published: 25/07/2023 View Suomi (FI) (48.72 KB - PDF) First published: 25/07/2023 View svenska (SV) (48.54 KB - PDF) First published: 25/07/2023 View 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 Expand section Collapse section 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 View Qaialdo : EPAR - Procedural steps taken and scientific information after the authorisation (archived) English (EN) (138.71 KB - PDF) First published: 20/02/2025 View 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 View 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 View 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 View 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 24/03/2026 Share this page