Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Lynparza   
Auth. number : EU/1/14/959
Active substance : Olaparib
Orphan market exclusivity for "Treatment of ovarian cancer" (based on designation EU/3/07/501) started on 18/12/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 18/12/2024
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX46 - Olaparib
(See WHO ATC Index)
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.
Marketing Authorisation Holder: AstraZeneca AB
SE-151 85 Södertälje, Sverige
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
18/12/2014 Centralised - Authorisation EMEA/H/C/3726 (2014)10083 of 16/12/2014
04/04/2016 Centralised - 2-Monthly update EMEA/H/C/3726/II/1/G (2016)2014 of 31/03/2016
25/10/2016 Centralised - 2-Monthly update EMEA/H/C/3726/II/8 (2016)6882 of 21/10/2016
14/12/2016 Centralised - 2-Monthly update EMEA/H/C/3726/II/9/G (2016)8655 of 12/12/2016
12/06/2017 Centralised - Variation EMEA/H/C/3726/IB/17/G