Olanzapine Mylan

Because Olanzapine Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

The recommended starting dose of Olanzapine Mylan tablets depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day. The dose is adjusted depending on how well the patient responds to and tolerates the treatment. The usual dose range is between 5 and 20 mg per day. Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose of 5 mg per day. Olanzapine Mylan is not recommended for use in patients below 18 years of age because of a lack on information on safety and effectiveness in this age group.

The active substance in Olanzapine Mylan, olanzapine, is an antipsychotic medicine. It is known as an ‘atypical’ antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s. Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain. This disrupts signals transmitted between brain cells by ‘neurotransmitters’, chemicals that allow nerve cells to communicate with each other. It is thought that olanzapine’s beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine. Since these neurotransmitters are involved in schizophrenia and in bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.

The European Commission granted a marketing authorisation valid throughout the European Union for Olanzapine Mylan to Generics [UK] Ltd. on 7 October 2008.

Because Olanzapine Mylan is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (i.e. that the two medicines produce the same levels of the active substance in the body).

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Olanzapine Mylan has been shown to have comparable quality and to be bioequivalent to Zyprexa. Therefore, the CHMP’s view was that, as for Zyprexa, the benefit outweighs the identified risk. The Committee recommended that Olanzapine Mylan be given marketing authorisation.

Olanzapine Mylan is a medicine containing 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’. This means that Olanzapine Mylan is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Zyprexa.

Olanzapine Mylan is used to treat adults with schizophrenia. Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs). Olanzapine Mylan is also effective in maintaining improvement in patients who have responded to an initial course of 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 the recurrence (when symptoms come back) of these episodes in adults with bipolar disorder (a mental illness with alternating periods of high mood and depression) who have responded to an initial course of treatment.

The medicine can only be obtained with a prescription.

Olanzapine Viatris is available as tablets and is taken once a day. The dose depends on the disease being treated and may be adjusted depending on how well the patient responds to and tolerates the treatment.

The medicine can only be obtained with a prescription.

For more information about using Olanzapine Viatris, see the package leaflet or contact your doctor or pharmacist.

The active substance in Olanzapine Viatris, olanzapine, is an antipsychotic medicine. It is known as an ‘atypical’ antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s. Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain. This disrupts signals transmitted between brain cells by ‘neurotransmitters’, chemicals that allow nerve cells to communicate with each other.

It is thought that olanzapine’s beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine. Since these neurotransmitters are involved in schizophrenia and in bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zyprexa, and do not need to be repeated for Olanzapine Viatris.

As for every medicine, the company provided studies on the quality of Olanzapine Viatris. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Because Olanzapine Viatris 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.

The European Medicines Agency concluded that, in accordance with EU requirements, Olanzapine Viatris has been shown to have comparable quality and to be bioequivalent to Zyprexa. Therefore, the Agency’s view was that, as for Zyprexa, the benefits of Olanzapine Viatris outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Olanzapine Viatris have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Zyprexa also apply to Olanzapine Viatris where appropriate.

As for all medicines, data on the use of Olanzapine Viatris are continuously monitored. Suspected side effects reported with Olanzapine Viatris are carefully evaluated and any necessary action taken to protect patients.

Olanzapine Mylan received a marketing authorisation valid throughout the EU on 7 October 2008.

The name of the medicine was changed to Olanzapine Viatris on 15 October 2024.