Zypadhera (olanzapine)
- Region
- 🇪🇺 EU
- Active substance
- olanzapine
- Company
- CHEPLAPHARM Registration GmbH
- Status
- Authorised
- Therapeutic area
- Schizophrenia
- CHMP opinion
- Thu 25 Sep 2008
- EU approval
- Wed 19 Nov 2008
- Application
- EMEA/H/C/000890
- ATC
- N05AH03
- Official record
- www.ema.europa.eu
Indication
Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.
Regulatory milestones
Wed 27 Aug 2025🇪🇺 EU shortage
Zypadhera: shortage ongoing
Powder and solvent for prolonged-release suspension for injection; Expected resolution: October 2025; Alternatives available: Yes · source
Same substance in other markets
- 🇺🇸 Weltruza Approved · Teva
- 🇪🇺 Olazax Authorised · Glenmark Pharmaceuticals s.r.o.
- 🇪🇺 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- 🇪🇺 Olanzapine Apotex Withdrawn · Apotex Europe BV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- 🇪🇺 Olanzapine Cipla (previously Olanzapine Neopharma) Withdrawn · Cipla (EU) Limited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.