Olanzapine Mylan

olanzapine

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Olanzapine Mylan?

Olanzapine Mylan is a medicine containing the active substance olanzapine. It is available as white tablets (round: 2.5, 5, 7.5 and 10 mg; oval: 15 and 20 mg).

Olanzapine Mylan is a ‘generic medicine’. This means that Olanzapine Mylan is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Zyprexa.

What is Olanzapine Mylan used for?

Olanzapine Mylan is used to treat adults with schizophrenia. Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs). Olanzapine Mylan is also effective in maintaining improvement in patients who have responded to an initial course of treatment.

Olanzapine Mylan is also used to treat moderate to severe manic episodes (extremely high mood) in adults. It can also be used to prevent the recurrence (when symptoms come back) of these episodes in adults with bipolar disorder (a mental illness with alternating periods of high mood and depression) who have responded to an initial course of treatment.

The medicine can only be obtained with a prescription.

How is Olanzapine Mylan used?

The recommended starting dose of Olanzapine Mylan tablets depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day. The dose is adjusted depending on how well the patient responds to and tolerates the treatment. The usual dose range is between 5 and 20 mg per day. Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose of 5 mg per day. Olanzapine Mylan is not recommended for use in patients below 18 years of age because of a lack on information on safety and effectiveness in this age group.

How does Olanzapine Mylan work?

The active substance in Olanzapine Mylan, olanzapine, is an antipsychotic medicine. It is known as an ‘atypical’ antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s. Its exact mechanism of action is unknown, but it attaches to several 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. It is thought that olanzapine’s beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine. Since these neurotransmitters are involved in schizophrenia and in bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.

How has Olanzapine Mylan been studied?

Because Olanzapine Mylan is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (i.e. that the two medicines produce the same levels of the active substance in the body).

What is the risk associated with Olanzapine Mylan?

Because Olanzapine Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has Olanzapine Mylan been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Olanzapine Mylan has been shown to have comparable quality and to be bioequivalent to Zyprexa. Therefore, the CHMP’s view was that, as for Zyprexa, the benefit outweighs the identified risk. The Committee recommended that Olanzapine Mylan be given marketing authorisation.

Other information about Olanzapine Mylan

The European Commission granted a marketing authorisation valid throughout the European Union for Olanzapine Mylan to Generics [UK] Ltd. on 7 October 2008.

Name Language First published Last updated
Olanzapine Mylan : EPAR - Summary for the public BG = bălgarski 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public ES = español 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public CS = čeština 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public DA = dansk 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public DE = Deutsch 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public ET = eesti keel 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public EL = elliniká 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public EN = English 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public FR = français 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public IT = italiano 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public LV = latviešu valoda 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public LT = lietuvių kalba 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public HU = magyar 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public MT = Malti 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public NL = Nederlands 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public PL = polski 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public PT = português 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public RO = română 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public SK = slovenčina 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public SL = slovenščina 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public FI = suomi 16/10/2008  
Olanzapine Mylan : EPAR - Summary for the public SV = svenska 16/10/2008  

This EPAR was last updated on 03/02/2014 .

Authorisation details

Product details

Product details for Olanzapine Mylan
NameOlanzapine Mylan
Agency product numberEMEA/H/C/000961
Active substance

olanzapine

International non-proprietary name (INN) or common name

olanzapine

Therapeutic area Bipolar DisorderSchizophrenia
Anatomical therapeutic chemical (ATC) code N05AH03
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 Olanzapine Mylan
Marketing-authorisation holder

Generics [UK] Ltd.

Revision8
Date of issue of marketing authorisation valid throughout the European Union07/10/2008

Contact address:

Generics [UK] Limited
Station Close
Potters Bar
Hertfordshire
EN6 1TL
United Kingdom

Product information

Product information

31/10/2013  Olanzapine Mylan -EMEA/H/C/000961 -IB/34/G

Name Language First published Last updated
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014
Olanzapine Mylan : EPAR - Product Information SV = svenska 24/11/2009 03/02/2014

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
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014
Olanzapine Mylan : EPAR - All Authorised presentations SV = svenska 18/12/2008 03/02/2014

Pharmacotherapeutic group

Psycholeptics

Therapeutic indication

Adults

Olanzapine is indicated for the treatment of schizophrenia.

Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.

Olanzapine is indicated for the treatment of moderate to severe manic episode.

In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Olanzapine Mylan : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 24/11/2009 03/02/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Olanzapine Mylan : EPAR - Public assessment report SV = svenska 16/10/2008  
Committee for medicinal products for human use, summary of positive opinion for Olanzapine Mylan SV = svenska 24/07/2008  

Authorised

This medicine is approved for use in the European Union

More information on Olanzapine Mylan