Aripiprazole Zentiva

aripiprazole

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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.

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 summary of the risk management plan.

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.

Name Language First published Last updated
Aripiprazole Zentiva : EPAR - Summary for the public BG = bălgarski 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public ES = español 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public CS = čeština 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public DA = dansk 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public DE = Deutsch 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public ET = eesti keel 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public EL = elliniká 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public FR = français 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public IT = italiano 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public LV = latviešu valoda 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public LT = lietuvių kalba 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public HU = magyar 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public MT = Malti 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public NL = Nederlands 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public PL = polski 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public PT = português 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public RO = română 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public SK = slovenčina 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public SL = slovenščina 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public FI = suomi 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public SV = svenska 30/07/2015  
Aripiprazole Zentiva : EPAR - Summary for the public HR = Hrvatski 30/07/2015  
Name Language First published Last updated
Aripiprazole Zentiva : EPAR - Risk-management-plan summary (English only) 30/07/2015  

This EPAR was last updated on 21/04/2016 .

Authorisation details

Product details

Product details for Aripiprazole Zentiva
NameAripiprazole Zentiva
Agency product numberEMEA/H/C/003899
Active substance

aripiprazole

International non-proprietary name (INN) or common name

aripiprazole

Therapeutic area Bipolar DisorderSchizophrenia
Anatomical therapeutic chemical (ATC) code N05AX12
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Aripiprazole Zentiva
Marketing-authorisation holder

Zentiva, k.s.

Revision1
Date of issue of marketing authorisation valid throughout the European Union25/06/2015

Contact address:

Zentiva, k.s.
U kabelovny 130
Dolni Mecholupy
102 37 Prague 10
Czech Republic

Product information

Product information

17/03/2016  Aripiprazole Zentiva -EMEA/H/C/003899 -IB/0002/G

Name Language First published Last updated
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016
Aripiprazole Zentiva : EPAR - Product Information EN = English 30/07/2015 21/04/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  
Aripiprazole Zentiva : EPAR - All Authorised presentations EN = English 30/07/2015  

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Aripiprazole Zentiva : EPAR - Procedural steps taken and scientific information after authorisation EN = English 21/04/2016  

Initial marketing-authorisation documents

Name Language First published Last updated
Aripiprazole Zentiva : EPAR - Public assessment report EN = English 30/07/2015  
CHMP summary of positive opinion for Aripiprazole Zentiva EN = English 24/04/2015  

Authorised

This medicine is approved for use in the European Union

More information on Aripiprazole Zentiva