What is Olanzapine Mylan?
Olanzapine Mylan is a medicine that contains the active substance olanzapine. It is available as white tablets (round: 2.5, 5, 7.5 and 10 mg; oval: 15 and 20 mg).
Olanzapine Mylan is a 'generic medicine', which means that it is similar to a 'reference medicine' already authorized in the European Union (EU) called Zyprexa. For more information on generic medicines, see the questions and answers by clicking here.
What is Olanzapine Mylan used for?
Olanzapine Mylan 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, suspiciousness and delusions. Olanzapine Mylan is also effective in maintaining clinical improvement in patients who have responded positively to initial treatment.
Olanzapine Mylan is also used to treat moderate to severe manic episodes (extremely high mood) in adults. It can also be used to prevent manic episodes from returning (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 Olanzapine Mylan used?
The recommended starting dose of Olanzapine Mylan tablets depends on the disease being 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 it is used in combination with other medicines, in which case the starting dose may be 10 mg per day. Dosage can be adapted to patient response and therapy tolerance. The usual dose varies between 5 and 20 mg per day. The starting 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. Olanzapine Mylan is not recommended for use in patients below 18 years of age due to a lack of data on the safety and efficacy of the product for this age group.
How does Olanzapine Mylan work?
The active substance in Olanzapine Mylan, olanzapine, is an antipsychotic agent. It is known as an "atypical" antipsychotic, as it differs from the old antipsychotic drugs available since the 1950s. Although its exact mechanism of action is not known, it is nevertheless linked to some receptors on the surface of nerve cells in the brain. . This disrupts the signals transmitted between brain cells through neurotransmitters, the chemicals that allow nerve cells to communicate with each other. Olanzapine's beneficial effect is thought to be due to its ability to block receptors. for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine. Since these neurotransmitters are implicated in schizophrenia and bipolar disorder, olanzapine contributes to the normalization of brain activity, reducing the symptoms of these diseases.
How has Olanzapine Mylan been studied?
Since Olanzapine Mylan is a generic medicine, studies have been limited to tests to show that the medicine is bioequivalent to the reference medicine (ie that the two medicines produce the same levels of the active substance in the body).
What is the risk associated with Olanzapine Mylan?
Since Olanzapine Mylan is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks of the medicine are assumed to be the same.
Why has Olanzapine Mylan been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the required requirements of EU legislation, Olanzapine Mylan has been shown to have comparable quality and to be bioequivalent to Zyprexa. It is therefore the view of the CHMP that, as in the case of Zyprexa, the benefits outweigh the identified risks. The Committee recommended that Olanzapine Mylan be given marketing authorization.
More information about Olanzapine Mylan
On 7 October 2008, the European Commission granted Generics [UK] Ltd. a "Marketing Authorization" for Olanzapine Mylan, valid throughout the European Union.
For the full version of the Olanzapine Mylan EPAR click here.
The full EPAR version of the reference medicine can also be found on the EMEA website.
Last update of this summary: 08-2008
The information on Olanzapine Mylan 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.
