🇪🇺 Olaparib tablets in European Union

EMA authorised Olaparib tablets on 16 December 2014

Marketing authorisation

EMA — authorised 16 December 2014

  • Application: EMEA/H/C/003726
  • Marketing authorisation holder: AstraZeneca AB
  • Local brand name: Lynparza
  • Indication: Ovarian cancer Lynparza is indicated as monotherapy for the: maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. Lynparza in
  • Status: approved

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Frequently asked questions

Is Olaparib tablets approved in European Union?

Yes. EMA authorised it on 16 December 2014.

Who is the marketing authorisation holder for Olaparib tablets in European Union?

AstraZeneca AB holds the EU marketing authorisation.