Olanzapine Apotex (olanzapine)
- Region
- 🇪🇺 EU
- Active substance
- olanzapine
- Company
- Apotex Europe BV
- Status
- Withdrawn
- Therapeutic area
- Schizophrenia; Bipolar Disorder
- EU approval
- Thu 10 Jun 2010
- Designations
- Generic
- Application
- EMEA/H/C/001178
- ATC
- N05AH03
- Official record
- www.ema.europa.eu
Indication
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.
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
- 🇪🇺 Zyprexa Authorised · CHEPLAPHARM Registration GmbH
- 🇪🇺 Olanzapine Viatris (previously Olanzapine Mylan) Authorised · Viatris Limited
- 🇪🇺 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- 🇪🇺 Olanzapine Cipla (previously Olanzapine Neopharma) Withdrawn · Cipla (EU) Limited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.