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EMA Product

Olanzapine Glenmark

Product approved by European Medicines Agency (EU)

Basic Information

Olanzapine Glenmark

Regulatory Information

EMEA/H/C/001085

Authorised

December 3, 2009

15

December 20, 2022

Company Information

Germany

Glenmark Arzneimittel GmbH Industriestr. 31 D – 82194 Gröbenzell

Glenmark Arzneimittel GmbH

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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