Human medicines European public assessment report (EPAR): Aripiprazole Zentiva, aripiprazole, Date of authorisation: 25/06/2015, Revision: 14, Status: Authorised

Aripiprazole Zentiva RSS Authorised This medicine is authorised for use in the European Union aripiprazole Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview This is a summary of the European public assessment report (EPAR) for Aripiprazole Zentiva. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Aripiprazole Zentiva. For practical information about using Aripiprazole Zentiva, patients should read the package leaflet or contact their doctor or pharmacist. Expand section Collapse section What is Aripiprazole Zentiva and what is it used for? Aripiprazole Zentiva is used in patients with the following mental illnesses: schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs). Aripiprazole Zentiva is used in patients aged 15 years or over; bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood. They may also have episodes of depression. Aripiprazole Zentiva is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past. Aripiprazole Zentiva is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over. Aripiprazole Zentiva contains the active substance aripiprazole and is a ‘generic medicine’. This means that Aripiprazole Zentiva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Abilify. How is Aripiprazole Zentiva used? Aripiprazole Zentiva is available as tablets (5, 10, 15 and 30 mg) and orodispersible tablets (tablets that dissolve in the mouth; 10, 15 and 30 mg). It can only be obtained with a prescription. For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a ‘maintenance’ dose of 15 mg once a day. In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day. For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines. To prevent manic episodes in adults, the same dose should be continued. For treating manic episodes in patients aged between 13 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day. Treatment must not last longer than 12 weeks. The dose should be adjusted in patients who are taking other medicines that affect the way Aripiprazole Zentiva is broken down in the body. For further information, see the Summary of Product Characteristics (also part of the EPAR). The orodispersible tablets can be used in patients who have difficulty swallowing tablets. How does Aripiprazole Zentiva work? The active substance in Aripiprazole Zentiva, aripiprazole, is an antipsychotic medicine. Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain. This disrupts signals transmitted between brain cells by ‘neurotransmitters’, chemicals that allow nerve cells to communicate with each other. Aripiprazole is thought to act mainly by being a ‘partial agonist’ for the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin). This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters. Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning. How has Aripiprazole Zentiva been studied? Because Aripiprazole Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Abilify. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. What are the benefits and risks of Aripiprazole Zentiva? Because Aripiprazole Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s. Why is Aripiprazole Zentiva approved? The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Zentiva has been shown to have comparable quality and to be bioequivalent to Abilify. Therefore, the CHMP’s view was that, as for Abilify, the benefit outweighs the identified risk. The Committee recommended that Aripiprazole Zentiva be approved for use in the EU. What measures are being taken to ensure the safe and effective use of Aripiprazole Zentiva? A risk management plan has been developed to ensure that Aripiprazole Zentiva is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aripiprazole Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients. Further information can be found in the Aripiprazole Zentiva : EPAR - Risk-management-plan summary . In addition, the company that markets Aripiprazole Zentiva will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years. Other information about Aripiprazole Zentiva The European Commission granted a marketing authorisation valid throughout the European Union for Aripiprazole Zentiva on 25 June 2015. For more information about treatment with Aripiprazole Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Aripiprazole Zentiva : EPAR - Summary for the public English (EN) (100.03 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View Other languages (22) български (BG) (124.19 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View español (ES) (102.42 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View čeština (CS) (120.72 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View dansk (DA) (101 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View Deutsch (DE) (104 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View eesti keel (ET) (101.53 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View ελληνικά (EL) (125.9 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View français (FR) (103.64 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View hrvatski (HR) (109.75 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View italiano (IT) (102.37 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View latviešu valoda (LV) (117.21 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View lietuvių kalba (LT) (110.66 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View magyar (HU) (110.87 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View Malti (MT) (119.84 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View Nederlands (NL) (102.78 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View polski (PL) (120.05 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View português (PT) (103.18 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View română (RO) (119.21 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View slovenčina (SK) (120.36 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View slovenščina (SL) (109.01 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View Suomi (FI) (101.27 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View svenska (SV) (100.81 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View Aripiprazole Zentiva : EPAR - Risk-management-plan summary English (EN) (59.84 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View Product information Aripiprazole Zentiva : EPAR - Product Information English (EN) (328.48 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View Other languages (24) български (BG) (451.05 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View español (ES) (353.05 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View čeština (CS) (379.41 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View dansk (DA) (427.27 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View Deutsch (DE) (357.15 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View eesti keel (ET) (381.49 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View ελληνικά (EL) (543.08 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View français (FR) (402.62 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View hrvatski (HR) (422.43 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View íslenska (IS) (309.3 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View italiano (IT) (867.54 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View latviešu valoda (LV) (418.16 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View lietuvių kalba (LT) (506.06 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View magyar (HU) (410.51 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View Malti (MT) (507.92 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View Nederlands (NL) (382.04 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View norsk (NO) (320.64 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View polski (PL) (442.66 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View português (PT) (281.55 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View română (RO) (586.1 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View slovenčina (SK) (480.79 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View slovenščina (SL) (398.63 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View Suomi (FI) (332.04 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View svenska (SV) (371.53 KB - PDF) First published: 30/07/2015 Last updated: 08/04/2026 View Latest procedure affecting product information: VR/0000337489 08/04/2026 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). Aripiprazole Zentiva : EPAR - All Authorised presentations English (EN) (12.08 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View Other languages (24) български (BG) (29.05 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View español (ES) (36.95 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View čeština (CS) (39.22 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View dansk (DA) (32.36 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View Deutsch (DE) (21.28 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View eesti keel (ET) (31.95 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View ελληνικά (EL) (41.95 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View français (FR) (28.61 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View hrvatski (HR) (31.33 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View íslenska (IS) (16.76 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View italiano (IT) (24.48 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View latviešu valoda (LV) (40.4 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View lietuvių kalba (LT) (41.42 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View magyar (HU) (30.92 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View Malti (MT) (25.57 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View Nederlands (NL) (25.64 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View norsk (NO) (31.72 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View polski (PL) (32.54 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View português (PT) (19.56 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View română (RO) (27.67 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View slovenčina (SK) (39.06 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View slovenščina (SL) (32.31 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View Suomi (FI) (24.1 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View svenska (SV) (26.11 KB - PDF) First published: 30/07/2015 Last updated: 17/06/2025 View Product details Name of medicine Aripiprazole Zentiva Active substance aripiprazole International non-proprietary name (INN) or common name aripiprazole Therapeutic area (MeSH) Schizophrenia Bipolar Disorder Anatomical therapeutic chemical (ATC) code N05AX12 Pharmacotherapeutic group Psycholeptics Therapeutic indication Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older. Authorisation details EMA product number EMEA/H/C/003899 Generic This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines . Marketing authorisation holder Zentiva, k.s. U kabelovny 130 Dolni Mecholupy 102 37 Prague 10 Czech Republic Opinion adopted 23/04/2015 Marketing authorisation issued 25/06/2015 Revision 14 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Aripiprazole Zentiva : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (140.63 KB - PDF) First published: 17/06/2025 Last updated: 08/04/2026 View Aripiprazole Zentiva : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (126.23 KB - PDF) First published: 21/04/2016 Last updated: 17/06/2025 View Initial marketing authorisation documents Aripiprazole Zentiva : EPAR - Public assessment report Adopted Reference Number: EMA/CHMP/232319/2015 English (EN) (668.21 KB - PDF) First published: 30/07/2015 Last updated: 30/07/2015 View CHMP summary of positive opinion for Aripiprazole Zentiva Adopted Reference Number: EMA/CHMP/232372/2015 English (EN) (68.81 KB - PDF) First published: 24/04/2015 Last updated: 24/04/2015 View News on Aripiprazole Zentiva Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015 24/04/2015 More information on Aripiprazole Zentiva Questions and answers on generic medicines Reference Number: EMA/393905/2006 Rev. 2 English (EN) (66.45 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View Other languages (22) български (BG) (93.16 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View español (ES) (68.3 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View čeština (CS) (87.71 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View dansk (DA) (66.79 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View Deutsch (DE) (67.55 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View eesti keel (ET) (65.21 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View ελληνικά (EL) (91.29 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View français (FR) (68.35 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View hrvatski (HR) (87.8 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View italiano (IT) (67.62 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View latviešu valoda (LV) (111.81 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View lietuvių kalba (LT) (86.76 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View magyar (HU) (85.76 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View Malti (MT) (89.35 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View Nederlands (NL) (66.81 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View polski (PL) (88.51 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View português (PT) (68.32 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View română (RO) (86.9 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View slovenčina (SK) (87.73 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View slovenščina (SL) (84.8 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View Suomi (FI) (66.21 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View svenska (SV) (67.11 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View Product information - with tracked changes The approved product information for this medicine is available below showing the changes since the previous procedure affecting the product information. The same document without tracked changes is above under 'Product information'. Aripiprazole Zentiva : EPAR – Product information – tracked changes English (EN) (127.59 KB - DOCX) First published: 17/07/2025 View Other languages (24) български (BG) (181.79 KB - DOCX) First published: 17/07/2025 View español (ES) (122.04 KB - DOCX) First published: 17/07/2025 View čeština (CS) (152.09 KB - DOCX) First published: 17/07/2025 View dansk (DA) (245.65 KB - DOCX) First published: 17/07/2025 View Deutsch (DE) (140.47 KB - DOCX) First published: 17/07/2025 View eesti keel (ET) (174.39 KB - DOCX) First published: 17/07/2025 View ελληνικά (EL) (200.13 KB - DOCX) First published: 17/07/2025 View français (FR) (305.83 KB - DOCX) First published: 17/07/2025 View hrvatski (HR) (118.84 KB - DOCX) First published: 17/07/2025 View íslenska (IS) (136.94 KB - DOCX) First published: 17/07/2025 View italiano (IT) (258.03 KB - DOCX) First published: 17/07/2025 View latviešu valoda (LV) (131.75 KB - DOCX) First published: 17/07/2025 View lietuvių kalba (LT) (140.18 KB - DOCX) First published: 17/07/2025 View magyar (HU) (121.27 KB - DOCX) First published: 17/07/2025 View Malti (MT) (199.07 KB - DOCX) First published: 17/07/2025 View Nederlands (NL) (201.31 KB - DOCX) First published: 17/07/2025 View norsk (NO) (136.52 KB - DOCX) First published: 17/07/2025 View polski (PL) (141.08 KB - DOCX) First published: 17/07/2025 View português (PT) (120.23 KB - DOCX) First published: 17/07/2025 View română (RO) (147.76 KB - DOCX) First published: 17/07/2025 View slovenčina (SK) (143.75 KB - DOCX) First published: 17/07/2025 View slovenščina (SL) (130.46 KB - DOCX) First published: 17/07/2025 View Suomi (FI) (138.21 KB - DOCX) First published: 17/07/2025 View svenska (SV) (182.58 KB - DOCX) First published: 17/07/2025 View Topics Generic and hybrid medicines Medicines This page was last updated on 08/04/2026 Share this page