Zalasta

olanzapine

  • Email
  • Help

About

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 Zalasta?

Zalasta is a medicine containing the active substance olanzapine. It is available as round, yellow tablets (2.5, 5, 7.5, 10, 15 and 20 mg) and as round, yellow ‘orodispersible’ tablets (5, 7.5, 10, 15 and 20 mg). Orodispersible tablets are tablets that dissolve in the mouth.

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

What is Zalasta used for?

Zalasta 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). Zalasta is also effective in maintaining improvement in patients who have responded to an initial course of treatment.

Zalasta is also used to treat moderate to severe manic episodes (extremely high mood) in adults. It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness causing 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 Zalasta used?

The recommended starting dose of Zalasta 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. The orodispersible tablets, which can be used as an alternative to the tablets, are taken by being placed on the tongue, where they disintegrate quickly in the saliva, or by mixing them in water before swallowing. 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.

How does Zalasta work?

The active substance in Zalasta, 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-hydroxytryptamine (also called serotonin) and dopamine. Since these neurotransmitters are involved in schizophrenia and bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.

How has Zalasta been studied?

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

What are the benefit and risk of Zalasta?

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

Why has Zalasta been approved?

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

Other information about Zalasta

The European Commission granted a marketing authorisation valid throughout the EU for Zalasta to KRKA, d.d., Novo mesto on 27 September 2007. 

Name Language First published Last updated
Zalasta : EPAR - Summary for the public BG = bălgarski 2008-11-17  
Zalasta : EPAR - Summary for the public ES = español 2008-11-17  
Zalasta : EPAR - Summary for the public CS = čeština 2008-11-17  
Zalasta : EPAR - Summary for the public DA = dansk 2008-11-17  
Zalasta : EPAR - Summary for the public DE = Deutsch 2008-11-17  
Zalasta : EPAR - Summary for the public ET = eesti keel 2008-11-17  
Zalasta : EPAR - Summary for the public EL = elliniká 2008-11-17  
Zalasta : EPAR - Summary for the public EN = English 2008-11-17  
Zalasta : EPAR - Summary for the public FR = français 2008-11-17  
Zalasta : EPAR - Summary for the public IT = italiano 2008-11-17  
Zalasta : EPAR - Summary for the public LV = latviešu valoda 2008-11-17  
Zalasta : EPAR - Summary for the public LT = lietuvių kalba 2008-11-17  
Zalasta : EPAR - Summary for the public HU = magyar 2008-11-17  
Zalasta : EPAR - Summary for the public MT = Malti 2008-11-17  
Zalasta : EPAR - Summary for the public NL = Nederlands 2008-11-17  
Zalasta : EPAR - Summary for the public PL = polski 2008-11-17  
Zalasta : EPAR - Summary for the public PT = português 2008-11-17  
Zalasta : EPAR - Summary for the public RO = română 2008-11-17  
Zalasta : EPAR - Summary for the public SK = slovenčina 2008-11-17  
Zalasta : EPAR - Summary for the public SL = slovenščina 2008-11-17  
Zalasta : EPAR - Summary for the public FI = suomi 2008-11-17  
Zalasta : EPAR - Summary for the public SV = svenska 2008-11-17  

This EPAR was last updated on 06/02/2018 .

Authorisation details

Product details

Product details for Zalasta
NameZalasta
Agency product numberEMEA/H/C/000792
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 Zalasta
Marketing-authorisation holder

Krka

Revision15
Date of issue of marketing authorisation valid throughout the European Union27/09/2007

Contact address:

Krka
Smarjeska cesta 6
SI-8501 Novo mesto
Slovenia

Product information

Product information

19/01/2018  Zalasta -EMEA/H/C/000792 -N/0034

Name Language First published Last updated
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06
Zalasta : EPAR - Product Information SV = svenska 2009-11-30 2018-02-06

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
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  
Zalasta : EPAR - All Authorised presentations SV = svenska 2007-10-28  

Pharmacotherapeutic group

Psycholeptics

Therapeutic indication

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
Zalasta : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-11-30 2018-02-06

Initial marketing-authorisation documents

Name Language First published Last updated
Zalasta : EPAR - Procedural steps taken before authorisation SV = svenska 2007-10-28  
Zalasta : EPAR - Scientific Discussion SV = svenska 2007-10-28  

Authorised

This medicine is approved for use in the European Union

More information on Zalasta