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Parliamentary questions
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10 January 2019
Question for written answer E-000110-19
to the Commission
Rule 130
Piernicola Pedicini (EFDD) , Marco Zullo (EFDD)

 Subject:  Authorisation to place on the market the medicinal product Lynparza (Olaparib) for the first-line treatment of patients with ovarian cancer
 Answer in writing 

In 2014, the medicinal product Lynparza, based on Olaparib, was authorised to be placed on the market in the European Union solely for the second-line treatment of patients with ovarian cancer.

However, Lynparza has not yet been authorised commercially for first-line treatment in the European Union.

A centralised authorisation procedure has been put in place, which involves evaluations by the Committee for Medicinal Products for Human Use (CHMP) and the European Medicines Agency (EMA).

In the light of the above, can the Commission answer the following questions:
1. Are the evaluations for the marketing authorisation for Lynparza (based on Olaparib) for the first-line treatment of patients with ovarian cancer under way?
2. When is the authorisation procedure due to be concluded?
3. The EMA business plan, now in phase 4, has been the subject of further suspensions and temporary reductions of staff since 1 January 2019. To what extent have these disruptions contributed to the delays in the authorisation procedure and continue to do so?
Original language of question: IT 
Last updated: 23 January 2019Legal notice