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(Application for interim measures - Marketing authorisation for a medicinal product - Ultrasound echocardiographic imaging agent for diagnostic purposes (perflubutane) - Refusal by the EMEA to grant a waiver from the obligation to submit a paediatric investigation plan - Application for suspension of operation of a measure and interim measures - No urgency)
2009/C 141/91
Language of the case: English
Applicant: Nycomed Danmark ApS (Roskilde, Denmark) (represented by: C. Schoonderbeek and H. Speyart van Woerden, lawyers)
Defendant: European Medicines Agency (EMEA) (represented by: V. Salvatore and N. Rampal Olmedo, Agents)
APPLICATION, first, for suspension of the operation of the EMEA’s decision of 28 November 2008 rejecting the application for a product-specific waiver concerning perflubutane and, secondly, for the grant of interim measures.
1.The application for interim measures is dismissed.
2.Costs are reserved.