Basic Information
Olanzapine Viatris (previously Olanzapine Mylan)
Regulatory Information
EMEA/H/C/000961
October 6, 2008
22
January 27, 2025
Company Information
Ireland
Damastown Industrial Park Mulhuddart Dublin Dublin 15
VIATRIS PHARMA LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication **Adults** Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.
Overview Summary
Olanzapine Viatris is used to treat adults with schizophrenia. Schizophrenia is a mental illness with symptoms such as delusions, disorganised thinking and speech, suspiciousness and hallucinations (seeing, hearing or feeling things that are not there). Olanzapine Viatris 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. Olanzapine Viatris contains the active substance olanzapine and is a ‘generic medicine’. This means that Olanzapine Viatris contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Olanzapine Viatris is Zyprexa. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf).