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Samples in periodicals archive:
Shire plc today announces a positive outcome from the European Decentralised Procedure (DCP) for Elvanse (to be known as Tyvense in Ireland).
Of the 25 member states involved in the EU Decentralised Procedure (DCP) for Rapinyl, 21 consider this product to be approvable.
14 /PRNewswire-FirstCall/ -- Shire plc announces that core labelling information, part of Shire's Marketing Authorisation Application for Mezavant, has been agreed by the regulatory agencies for the 15 European countries (including UK, Germany, France and Spain) participating in the decentralised procedure.
It is great news that the completion of the European decentralised procedure for triptorelin embonate 6-month formulation was done in such a timely manner," added Rolland-Yves Mauvernay, President and Founder of Debiopharm Group.
The product was filed for registration using the decentralised procedure on certain key European markets; Italy, Spain, Germany, Portugal, Poland and the UK.