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Parliamentary questions
21 March 2017
E-000525/2017
Answer given by Mr Andriukaitis on behalf of the Commission

The Commission is aware that an application for an orphan medicinal product containing eteplirsen (Exondys 51) was submitted to the European Medicines Agency in December 2016(1). The application is currently under the assessment of the Committee for Human Medicinal Product (CHMP), which has 210 days after the validation of the application to adopt an opinion, if no further questions are submitted to the applicant.

If the opinion of the CHMP concludes positively on the benefit/risk assessment of eteplirsen for the treatment of Duchenne's Syndrome and the Committee for Orphan Medicinal Products confirms the compliance with the orphan designation criteria in line with Regulation (EC) No 141/2000(2), the final decision on the authorisation is taken by the Commission.

(1)http://www.ema.europa.eu/docs/en_GB/document_library/Minutes/2017/02/WC500221405.pdf
(2)OJ L 18, 22.1.2000, p. 1‐5.

Last updated: 22 March 2017Legal notice