Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)

aripiprazole

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This is a summary of the European public assessment report (EPAR) for Aripiprazole PharmathenMylan Pharma. 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 PharmathenMylan Pharma. 

For practical information about using Aripiprazole PharmathenMylan Pharma, patients should read the package leaflet or contact their doctor or pharmacist.

What is Aripiprazole Mylan Pharma and what is it used for?

Aripiprazole Pharmathen 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 Pharmathen 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 Pharmathen 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 Pharmathen is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.

Aripiprazole Pharmathen contains the active substance aripiprazole and is a ‘generic medicine’. This means that Aripiprazole Pharmathen is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Abilify.

How is Aripiprazole Mylan Pharma used?

Aripiprazole Mylan Pharma is available as tablets (5, 10, 15 and 30 mg) and 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 Mylan Pharma is broken down in the body. For further information, see the Summary of Product Characteristics (also part of the EPAR).

How does Aripiprazole Mylan Pharma work?

The active substance in Aripiprazole Mylan Pharma, 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 Mylan Pharma been studied?

Because Aripiprazole Mylan Pharma 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 Mylan Pharma?

Because Aripiprazole Mylan Pharma 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 Mylan Pharma approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Mylan Pharma 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 Mylan Pharma be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Aripiprazole Mylan Pharma?

A risk management plan has been developed to ensure that Aripiprazole Mylan Pharma 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 Mylan Pharma, 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 Mylan Pharma 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 Mylan Pharma

Aripiprazole Pharmathen on 30 June 2015. The name of the medicine was changed to Aripiprazole Mylan Pharma on 3 June 2016.

For more information about treatment with Aripiprazole Mylan Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Aripiprazole Mylan Pharma : EPAR - Summary for the public BG = bălgarski 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public ES = español 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public CS = čeština 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public DA = dansk 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public DE = Deutsch 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public ET = eesti keel 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public EL = elliniká 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public EN = English 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public FR = français 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public IT = italiano 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public LV = latviešu valoda 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public LT = lietuvių kalba 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public HU = magyar 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public MT = Malti 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public NL = Nederlands 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public PL = polski 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public PT = português 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public RO = română 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public SK = slovenčina 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public SL = slovenščina 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public FI = suomi 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public SV = svenska 20/07/2015 08/07/2016
Aripiprazole Mylan Pharma : EPAR - Summary for the public HR = Hrvatski 20/07/2015 08/07/2016
Name Language First published Last updated
Aripiprazole Mylan Pharma : EPAR - Risk-management-plan summary (English only) 20/07/2015 08/07/2016

This EPAR was last updated on 08/08/2016 .

Authorisation details

Product details

Product details for Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
NameAripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
Agency product numberEMEA/H/C/003803
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 Mylan Pharma (previously Aripiprazole Pharmathen)
Marketing-authorisation holder

Mylan S.A.S

Revision3
Date of issue of marketing authorisation valid throughout the European Union30/06/2015

Contact address:

Mylan S.A.S
117 Allee des Parcs
69800 Saint-Priest
France

Product information

Product information

01/08/2016  Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) -EMEA/H/C/003803 -T/0005

Name Language First published Last updated
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016
Aripiprazole Mylan Pharma : EPAR - Product Information EN = English 20/07/2015 08/08/2016

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 Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016
Aripiprazole Pharmathen : EPAR - All Authorised presentations EN = English 20/07/2015 08/07/2016

Pharmacotherapeutic group

Psycholeptics

Therapeutic indication

Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.

Aripiprazole Mylan Pharma 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 Mylan Pharma 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 Mylan Pharma : EPAR - Procedural steps taken and scientific information after authorisation EN = English 18/04/2016 08/08/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Aripiprazole Pharmathen : EPAR - Public assessment report EN = English 20/07/2015  
CHMP summary of positive opinion for Aripiprazole Pharmathen EN = English 24/04/2015  

Authorised

This medicine is approved for use in the European Union

More information on Aripiprazole Pharmathen