Zejula

niraparib

Table of contents

Opinion

On 17 September 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Zejula. The marketing authorisation holder for this medicinal product is GlaxoSmithKline (Ireland) Limited.

The CHMP adopted an extension to the existing indication as follows:*

Zejula is indicated:

  • as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
  • as monotherapy for the maintenance treatment of adult patients with platinum‑sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum‑based chemotherapy.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


*New text in bold

Key facts

Name
Zejula
Agency product number
EMEA/H/C/004249
International non-proprietary name (INN) or common name
  • niraparib
Active substance
  • Niraparib (tosylate monohydrate)
Therapeutic area
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Ovarian Neoplasms
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
17/09/2020
Company name
GlaxoSmithKline (Ireland) Limited
Status
Positive
Application type
Post-authorisation

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