What is Olazax Disperzi?
Olazax Disperzi is a medicine that contains the active substance olanzapine. It is available in yellow orodispersible circular 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 it is similar to 'reference medicines' already authorized in the European Union (EU) called Zyprexa and Zyprexa Velotab.
What is Olazax Disperzi used for?
Olazax Disperzi is used to treat adults with schizophrenia. Schizophrenia is a mental disorder characterized by a number of symptoms, including thought and speech disorders, hallucinations (seeing or hearing things that are not there), suspiciousness and delusions (false beliefs). Olazax Disperzi is also effective in maintaining clinical improvement in patients who have responded positively to initial treatment.
Olazax Disperzi is also used to treat moderate to severe manic episodes (particularly high mood) in adults. The medicine can also be used to prevent these episodes from coming back (relapse) in adults with bipolar disorder (a mental disorder characterized by alternating euphoric and depressive phases) who have responded positively to initial treatment.
The medicine can only be obtained with a prescription.
How is Olazax Disperzi used?
The recommended starting dosage of Olazax Disperzi varies according to the type of disorder treated: for schizophrenia and the prevention of manic episodes it is 10 mg per day, for the treatment of manic episodes it is 15 mg per day, unless used in combination with other medicines, in which case the starting dose may be 10 mg per day. The dosage should be adjusted according to the patient's response and his degree of tolerance of the therapy. The usual dose can vary between 5 and 20 mg per day. The orodispersible tablets should be placed on the tongue, where they disperse in saliva, or they can be dissolved in a little water before taking. The starting dose may need to be reduced to 5 mg per day in patients over 65 years of age and in patients with liver or kidney problems.
How does Olazax Disperzi work?
The active ingredient in Olazax Disperzi, olanzapine, is an antipsychotic drug, known as an "atypical" antipsychotic, as it differs from the traditional antipsychotic drugs available since the 1950s. Although the exact mechanism of action of the " olanzipine, it attaches itself to several different types of receptors on the surface of nerve cells in the brain. This disrupts the signals transmitted between brain cells through “neurotransmitters”, ie the chemicals that allow nerve cells to communicate with each other. The beneficial effect of olanzapine is thought to be due to its ability to block the receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine. Since these neurotransmitters are implicated in schizophrenia and bipolar disorder, olanzapine contributes to normalization of " brain activity, reducing the symptoms of these diseases.
How has Olazax Disperzi been studied?
Since Olazax Disperzi is a generic medicine, the studies have limited themselves to providing evidence to establish that the medicine is bioequivalent to the reference medicines, Zyprexa and Zyprexa Velotab. Two medicines are said to be bioequivalent when they produce the same levels of the active ingredient in the body.
What are the risks and benefits associated with Olazax Disperzi?
Because Olazax Disperzi is a generic medicine and is bioequivalent to the reference medicines, the benefits and risks of the medicine are assumed to be the same as the reference medicines.
Why has Olazax Disperzi been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Olazax Disperzi has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab. It is therefore the CHMP's view that, as in the case of Zyprexa and Zyprexa Velotab, the benefits outweigh the identified risks. The Committee therefore recommended the granting of a marketing authorization for Olazax Disperzi.
Other information about Olazax Disperzi
On 10 December 2009, the European Commission granted Glenmark Pharmaceuticals sro. A "Marketing Authorization" for Olazax Disperzi, valid throughout the European Union. The "Marketing Authorization" is valid for five years and thereafter. period can be renewed.
For the complete version of Olazax Disperzi's EPAR, click here.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 10-2009
The information on Olazax Disperzi published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
