Olanzapine Neopharma

What is Olanzapine Neopharma?

Olanzapine Neopharma is a medicine containing the active substance olanzapine, available in the form of tablets (white and round 2.5, 5, 7.5 and 10 mg; blue and oval 15 mg).
Olanzapine Neopharma is a 'generic medicine'. This implies that it is similar to a 'reference medicine' already authorized in the European Union (EU) called Zyprexa. For more information on generic medicines, please see the questions and answers by clicking here.

What is Olanzapine Neopharma used for?

Olanzapine Neopharma is indicated for the treatment of adults with schizophrenia: Schizophrenia is a mental illness characterized by a range of symptoms, including thought and speech disorders, hallucinations (seeing or hearing things that are not there), suspiciousness and delusions. Olanzapine Neopharrma is also effective in maintaining clinical improvement in patients who have responded positively to initial treatment.
The drug is also used to treat moderate to severe manic episodes (particularly high mood) in adults. It can also be used to prevent manic episodes from returning (symptoms returning) in adults with bipolar disorder (a mental illness characterized by alternating manic and depressive phases) in patients who have responded to initial treatment.
The medicine can only be obtained with a prescription.

How is Olanzapine Neopharma used?

The recommended starting dosage of Olanzapine Neopharma 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 used in combination with other drugs, 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. It may be necessary to reduce the starting dose by 5 mg per day in patients over the age of 65 and in people with liver or kidney problems.

How does Olanzapine Neopharma work?

The active substance in Olanzapine Neopharma, olanzapine, is an antipsychotic drug, known as an "atypical" antipsychotic, as it differs from the older antipsychotic drugs available since the 1950s. While its exact mechanism of action is not known, it is nevertheless connected to a few different receptors on the surface of nerve cells in the brain. This disrupts the signals transmitted between brain cells through neurotransmitters, which are the chemicals that allow nerve cells to communicate with each other. The beneficial effect of olanzapine is 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 the normalization of brain activity, reducing the symptoms of these diseases.

How has Olanzapine Neopharma been studied?

Since Olanzapine Neopharma is a generic medicine, the studies have limited themselves to showing that the medicine is bioequivalent to the reference medicine (ie the two medicines produce the same levels of the active substance in the body).

What are the benefits and risks of Olanzapine Neopharma?

Since Olanzapine Neopharma 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 Neopharma been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the required requirements of EU legislation, Olanzapine Neopharma 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 Neopharma be given a Marketing Authorization.

Other information about Olanzapine Neopharma

On November 14, 2007, the European Commission granted Neopharma Limited a "Marketing Authorization" for Olanzapine Neopharma valid throughout the European Union.
Full versions of the EPAR for reference medicines can be found on the EMEA website.

Last update of this summary: 09-2008


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