What is Olazax?
Olazax is a medicine that contains the active substance olanzapine. It is available in circular, yellow (from 5, 7.5, 10, 15 and 20 mg) tablets.
Olazax is a "generic medicine". This means that it is similar to a "reference drug" already authorized in the European Union (EU) called Zyprexa.
What is Olazax used for?
Olazax is indicated for the treatment of adults with schizophrenia. Schizophrenia is a mental disorder characterized by a series of symptoms, including disorders of thought and language, hallucinations (hearing or seeing things that do not exist), suspiciousness and fixations (false convictions). Olazax is also effective in maintaining clinical improvement in patients who have responded positively to initial treatment.
Olazax is also used for the treatment of manic episodes (particularly euphoric mood) from moderate to severe in adults. The medicine can also be used to prevent the recurrence of such episodes (relapse) in adults with bipolar disorder (a mental disorder characterized by the alternation of euphoric phases and depressive phases) that have responded positively to the initial treatment.
The medicine can only be obtained with a prescription.
How is Olazax used?
The recommended initial dosage of Olazax varies according to the type of disorder being treated: 10 mg a day for schizophrenia and the prevention of manic episodes, 15 mg a day for the treatment of manic episodes, unless it is used in association with others drugs, in which case the initial dose may be 10 mg a day. The dosage should be adjusted according to the patient's response and the degree of tolerance of the therapy. The usual dose may vary between 5 and 20 mg a day. The initial dosage 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 work?
The active ingredient present in Olazax, olanzapine, is an antipsychotic drug, known as an "atypical" antipsychotic, as it differs from traditional antipsychotic drugs available since the 1950s. Although the exact mechanism of action of olanzapine is not known, it binds to different types of different receptors present on the surface of nerve cells in the brain. In this way the signals transmitted between the brain cells are disturbed through the "neurotransmitters", ie the chemicals that allow nerve cells to communicate with each other. It is believed that the beneficial effect of olanzapine is due to its ability to block receptors for neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine. Because these neurotransmitters are involved in schizophrenia and bipolar disorder, olanzapine contributes to the normalization of brain activity, reducing the symptoms of these diseases.
What studies have been carried out on Olazax?
Because Olazax is a generic medicine, the studies have been limited to providing evidence to show that the drug is bioequivalent to the reference medicine, Zyprexa. Two medicines are said to be bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Olazax?
Because Olazax 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 has Olazax been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of Community legislation, Olazax has been shown to have comparable quality and to be bioequivalent to Zyprexa. It is therefore the opinion of the CHMP that, as in the case of Zyprexa, the benefits outweigh the identified risks. The Committee therefore recommended that Olazax be given marketing authorization.
More information on Olazax
On 11 December 2009, the European Commission issued a marketing authorization for Glenaz Pharmaceuticals sro for Olazax, valid throughout the European Union. The marketing authorization is valid for five years and can be renewed after this period.
For the full EPAR of Olazax, click here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 10-2009
