| EMA number | EMEA/H/C/001178 |
| ATC code | N05AH03 |
| Authorisation | 10 June 2010 |
| Withdrawn | 12 August 2025 |
| Revision | 13 |
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.
OLANZAPINE — ASPIRO, approved 2023-03-22 (ANDA217466).
64,907 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.