Lynparza

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olaparib

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Lynparza and why it is authorised in the EU

Lynparza is a cancer medicine for treating recurring high-grade cancers of the ovary, fallopian tube (tubes connecting the ovary to the womb) and the peritoneum (a membrane lining the abdomen).

Lynparza is used as a maintenance treatment after the cancer has been reduced or cleared by a platinum-based chemotherapy.

It contains the active substance olaparib.

This EPAR was last updated on 28/05/2018

Authorisation details

Product details
Name
Lynparza
Agency product number
EMEA/H/C/003726
Active substance
Olaparib
International non-proprietary name (INN) or common name
olaparib
Therapeutic area (MeSH)
Ovarian Neoplasms
Anatomical therapeutic chemical (ATC) code
L01
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.

Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
16/12/2014
Contact address
SE-151 85 Södertälje
Sweden

Product information

08/05/2018 Lynparza - EMEA/H/C/003726 - X/0016/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTINEOPLASTIC AGENTS

Therapeutic indication

Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.

Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.

Assessment history

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