Basic Information
Olazax Disperzi
Regulatory Information
EMEA/H/C/001088
December 10, 2009
12
June 16, 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
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
This is a summary of the European public assessment report (EPAR) for Olazax Disperzi. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Olazax Disperzi.