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(Interim measures — Medicinal product — Marketing authorisation — Omega-3 acid ethyl esters — No urgency)
BASF AS, established in Oslo (Norway), represented by E. Wright, A. Rusanov and H. Boland, lawyers,
APPLICATION pursuant to Articles 278 and 279 TFEU for the grant of interim measures to suspend the operation of the Commission Implementing Decision of 6 June 2019 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use containing ‘Omega-3 acid ethyl esters’ for oral use in secondary prevention after myocardial infarction (C(2019) 4336 final),
According to the applicant, it is the marketing authorisation holder for, inter alia, the omega-3-acid ethyl ester medicinal products Omacor and Zodin.
Omacor was approved in 1995. The therapeutic indication relating to the treatment in secondary prevention after myocardial infarction was approved in 2001.
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