AstraZeneca Pharma India surrenders marketing authorisation for Olaparib 100mg and 150mg

AstraZeneca Pharma India surrenders marketing authorisation for Olaparib 100mg and 150mg

By: IPP Bureau

Last updated : April 16, 2025 9:39 am



The discontinuation decision is only on the basis of commercial reasons and is not due to efficacy or safety reasons


AstraZeneca Pharma India Limited had earlier announced the receipt of marketing authorisation dated November 17, 2023 for Olaparib film-coated tablets 100mg and 150mg (Lynparza) which was indicated in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer.

The Company has now surrendered the marketing authorisation of the above-mentioned indication of Olaparib (Lynparza) 100mg and 150mg.

Since the date of receipt of marketing authorisation for the said indications i.e. November 17, 2023, till date, we have never marketed the said indication in India.

The discontinuation decision is only on the basis of commercial reasons and is not due to efficacy or safety reasons. 

The company continues to hold all other existing permissions for the said drug Olaparib in India.

AstraZeneca Pharma India Olaparib

First Published : April 16, 2025 12:00 am