Is Olaparib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Olaparib, including Lynparza (100 mg, Film-coated tablet, SAR 15657.10); Lynparza (150 mg, Film-coated tablet, SAR 15657.10); Olaparib BOS (100 mg, Film-coated tablet, SAR 3914.25); Olaparib BOS (150 mg, Film-coated tablet, SAR 3914.25).

Is Olaparib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Olaparib, including LYNPARZA (Prescription); LYNPARZA (Discontinued).

Is Olaparib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Olaparib: Lynparza.

Are there safety signals or safety updates for Olaparib?

EMA PRAC: 6 entries; US FDA: 2 entries (latest 2025-07-10).

Active substance

Olaparib

SFDA 5
US FDA 2
EMA 1
Health Canada 2
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Lynparza	100 mg	Film-coated tablet · Oral use	112 Blister	SAR 15657.10	NCE · Prescription	AstraZeneca AB	Valid
Lynparza	150 mg	Film-coated tablet · Oral use	112 Blister	SAR 15657.10	NCE · Prescription	AstraZeneca AB	Valid
Olaparib BOS	100 mg	Film-coated tablet · Oral use	30 Blister	SAR 3914.25	Generic · Prescription	Boston Oncology Arabia	Valid
Olaparib BOS	150 mg	Film-coated tablet · Oral use	30 Blister	SAR 3914.25	Generic · Prescription	Boston Oncology Arabia	Valid
LYNPARZA 50 mg Capsule	50 mg	Capsule, hard · Oral use	448 Bottle	SAR 20876.15	NCE · Prescription	AstraZeneca AB	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

BREAST CANCER MET.HER-2 -VE; MALIGNANT NEOPLASM OF THE PANCREAS; OVARIAN CANCER; PROSTATE CANCER

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
LYNPARZA	100MG; 150MG	tablet · oral	ASTRAZENECA	Prescription	17 Aug 2017
LYNPARZA	50MG	capsule · oral	ASTRAZENECA	Discontinued	19 Dec 2014

EMA European Union — centrally authorised medicines

Lynparza AstraZeneca AB · Authorised · authorised 16 Dec 2014 · ATC L01XK01

Therapeutic indication (EMA)

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 combination with bevacizumab is indicated for the: maintenance treatment of adult patients with advanced (FIGO stages III and IV) 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 in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability (see section 5.1). Breast cancer Lynparza is indicated as: monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1). 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. Adenocarcinoma of the pancreas Lynparza is indicated as: monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. Prostate cancer Lynparza is indicated as: monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated (see section 5.1). Endometrial cancer Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LYNPARZA	02475200	100 MG	TABLET · ORAL	ASTRAZENECA CANADA INC
LYNPARZA	02475219	150 MG	TABLET · ORAL	ASTRAZENECA CANADA INC

Safety signals and safety-related labeling changes

US FDA 10 Jul 2025 LYNPARZA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 6 Jul 2023 PRAC signal: Hepatocellular damage and hepatitis
Action for MAH: update of the product information: Yes
EMA PRAC 16 Mar 2023 PRAC signal: Hepatocellular damage and hepatitis
Action for MAH: update of the product information: No
EMA PRAC 27 Oct 2022 PRAC signal: Hepatocellular damage and hepatitis
Action for MAH: update of the product information: No
EMA PRAC 8 Jul 2021 PRAC signal: Pneumocystis jirovecii pneumonia
Action for MAH: update of the product information: No
EMA PRAC 11 Feb 2021 PRAC signal: Pneumocystis jirovecii pneumonia
Action for MAH: update of the product information: No
EMA PRAC 14 May 2020 PRAC signal: Angioedema
Action for MAH: update of the product information: No
US FDA 27 Sep 2018 LYNPARZA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for olaparib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.