Olazax Disperzi
Authorised
This medicine is authorised for use in the European Union
olanzapine
MedicineHumanAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Olazax Disperzi. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Olazax Disperzi.
Olazax Disperzi is a medicine containing the active substance olanzapine. It is available as orodispersible tablets (5, 7.5, 10, 15 and 20 mg). Orodispersible tablets are tablets that dissolve in the mouth.
Olazax Disperzi is a ‘generic medicine’. This means that Olazax Disperzi is similar to ‘reference medicines’ already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotab.
Olazax Disperzi 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). Olazax Disperzi is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Olazax Disperzi 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 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.
The recommended starting dose of Olazax Disperzi 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 according to 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 are taken by being placed on the tongue, where they disintegrate in the saliva, or by mixing them in water before swallowing. Patients over 65 years of age and patients who reduced liver or kidney function may need a lower starting dose of 5 mg per day.
The active substance in Olazax Disperzi, 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 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. 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.
Because Olazax Disperzi is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicines, Zyprexa and Zyprexa Velotab. Medicines are bioequivalent when they produce the same levels of the active substance in the body.
Because Olazax Disperzi is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as the reference medicines.
The CHMP concluded that, in accordance with EU requirements, Olazax Disperzi 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 Olazax Disperzi be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the EU for Olazax Disperzi on 10 December 2009.
For more information about treatment with Olazax Disperzi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: PSUSA/00010540/201903
16/03/2020
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).
Product details
- Name of medicine
- Olazax Disperzi
- Active substance
- olanzapine
- International non-proprietary name (INN) or common name
- olanzapine
- Therapeutic area (MeSH)
- Schizophrenia
- Bipolar Disorder
- Anatomical therapeutic chemical (ATC) code
- N05AH03
Pharmacotherapeutic group
PsycholepticsTherapeutic 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.
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