What is Olanzapine Neopharma?
Olanzapine Neopharma is a drug containing the active substance olanzapine, available as 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 drug" 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 Neopharma used for?
Olanzapine Neopharma is indicated for the treatment of adults with schizophrenia: Schizophrenia is a mental illness characterized by a series of symptoms, including thought and speech disorders, hallucinations (seeing or hearing things that do not exist), 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 for the treatment of moderate to severe manic episodes in adults (particularly euphoric mood). It can also be used to prevent the recurrence of manic episodes (reappearance of symptoms) in adults with bipolar disorder (a mental illness characterized by the alternation of 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 initial dosage of Olanzapine Neopharma depends on the disease to be treated: for schizophrenia and the prevention of manic episodes it is 10 mg a day, for the treatment of manic episodes it is 15 mg a day, unless it is used in combination with other drugs, in which case the starting dose may be 10 mg a day. The dosage can be adapted to the patient's response and therapy tolerance. The usual dose varies between 5 and 20 mg a day. The initial dosage may need to be reduced by 5 mg per day in patients over the age of 65 and in subjects 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 old antipsychotic drugs available since the 1950s. Although its exact mechanism of action is not known, it is however linked to some different receptors on the surface of nerve cells in the brain. In this way the signals transmitted between the brain cells are interrupted through neurotransmitters, ie the chemical substances 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 performed on Olanzapine Neopharma?
Since Olanzapine Neopharma is a generic medicine, the studies have been limited to showing that the drug 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?
Because Olanzapine Neopharma is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks of the drug are supposed 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 requirements of EU legislation, Olanzapine Neopharma 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 risks identified. The committee recommended the granting of a marketing authorization for Olanzapine Neopharma.
More information on Olanzapine Neopharma
On 14 November 2007, the European Commission granted a marketing authorization valid for the entire European Union to Olanzapine Neopharma to Neopharma Limited.
The full EPAR versions for the reference medicines can be consulted on the EMEA website.
Last update of this summary: 09-2008
