What is Olazax?
Olazax is a medicine that contains the active substance olanzapine. It is available in circular, yellow tablets (5, 7.5, 10, 15 and 20 mg).
Olazax is a 'generic medicine'. This means that it is similar to a “reference medicine”, 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 number of symptoms, including thought and speech disorders, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs). Olazax is also effective in maintaining clinical improvement in patients who have responded positively to initial treatment.
Olazax 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 used?
The recommended starting dosage of Olazax varies according to the type of disorder treated: 10 mg per day for schizophrenia and the prevention of manic episodes, 15 mg per day for the treatment of manic episodes, unless used in combination with others. medications, 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 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 work?
The active substance 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 several different types of receptors found 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 been studied?
Because Olazax is a generic medicine, the studies have limited themselves to providing evidence to show that the medicine is bioequivalent to the reference medicine, Zyprexa. Two medicines are said to be bioequivalent when they produce the same levels of the 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, the benefits and risks of the medicine are assumed to be the same as the reference medicine.
Why has Olazax been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Olazax has been shown to have comparable quality and to be bioequivalent to Zyprexa. It is therefore the CHMP's view 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 about Olazax
On 11 December 2009, the European Commission released Glenmark Pharmaceuticals s.r.o. a "Marketing Authorization" for Olazax, valid throughout the European Union. The "Marketing Authorization" is valid for five years and can be renewed after that period.
For the full version of the Olazax 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
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