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EMA Product

Olazax

Product approved by European Medicines Agency (EU)

Basic Information

Olazax

Regulatory Information

EMEA/H/C/001087

Authorised

December 11, 2009

12

July 31, 2020

Company Information

Czech Republic

Glenmark Pharmaceuticals s.r.o. Hvezdova 1716/2b CZ-140 78 Praha 4

Glenmark Pharmaceuticals s.r.o.

Drug Classification

Generic Medicine

Active Substances Detail

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

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine. If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

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