Zyprexa (olanzapine)
- Region
- 🇪🇺 EU
- Active substance
- olanzapine
- Company
- CHEPLAPHARM Registration GmbH
- Status
- Authorised
- Therapeutic area
- Schizophrenia; Bipolar Disorder
- EU approval
- Fri 27 Sep 1996
- Application
- EMEA/H/C/000115
- ATC
- N05AH03
- Official record
- www.ema.europa.eu
Indication
Coated tablets 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. Injection Adults Zyprexa powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with Zyprexa powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇺🇸 Weltruza Approved · Teva
- 🇪🇺 Olazax Authorised · Glenmark Pharmaceuticals s.r.o.
- 🇪🇺 Zypadhera Authorised · CHEPLAPHARM Registration GmbH
- 🇪🇺 Olazax Disperzi Authorised · Glenmark Pharmaceuticals s.r.o.
- 🇪🇺 Olanzapine Glenmark Authorised · Glenmark Arzneimittel GmbH
- 🇪🇺 Olanzapine Glenmark Europe Authorised · Glenmark Arzneimittel GmbH
- 🇪🇺 Olanzapine Viatris (previously Olanzapine Mylan) Authorised · Viatris Limited
- 🇪🇺 Olanzapine Apotex Withdrawn · Apotex Europe BV
- 🇪🇺 Olanzapine Teva Authorised · Teva B.V.
- 🇪🇺 Zyprexa Velotab Authorised · CHEPLAPHARM Registration GmbH
- 🇪🇺 Zalasta Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Olanzapine Cipla (previously Olanzapine Neopharma) Withdrawn · Cipla (EU) Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.