| EMA number | EMEA/H/C/000114 |
| ATC code | N05AH03 |
| Authorisation | 7 October 1996 |
| Withdrawn | 17 March 2003 |
| Revision | - |
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. Olanzapine has not been demonstrated to prevent recurrence of manic or depressive episodes (see Section 5.1).
OLANZAPINE β 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 β they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.