Lynparza

RSS

olaparib

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

Overview

Lynparza is a cancer medicine used on its own for the treatment of:

  • high-grade (fast-growing) cancers of the ovaries, fallopian tubes (which connect the ovaries to the womb) and the peritoneum (membrane lining the abdomen) in patients whose cancer has been reduced or cleared by a platinum-based chemotherapy and who need continuing treatment;
  • a type of breast cancer (HER2-negative with BRCA mutations) that has spread beyond the original site in patients who have been treated with certain medicines or when these medicines are not suitable.

Lynparza contains the active substance olaparib.

This EPAR was last updated on 24/05/2019

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 monitoringAdditional 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
6
Date of issue of marketing authorisation valid throughout the European Union
16/12/2014
Contact address
SE-151 85 Södertälje
Sweden

Product information

08/04/2019 Lynparza - EMEA/H/C/003726 - II/0020

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Hard capsule

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.

Tablet

Ovarian cancer

Lynparza is indicated as monotherapy for the 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.

Breast cancer

Lynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see Section 5.1).

Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy or be considered unsuitable for endocrine therapy.

Assessment history

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