drugset / Press release

The Decentralised procedure used for the registration of ROVIs biosimilar of enoxaparin has been completed with positive outcome.

2017-03-07 · Rovi Pharmaceuticals Laboratories · original rovi.es ↗

TO THE NATIONAL STOCK MARKET COMMISSION Madrid, 7th of March, 2017 In compliance with the provisions of article 228 of the Securities Market Law and with Article 17 of the EU Regulation No. 596/2014 of European Parliament and Council, of the 16th of April, on market abuse, and further to the significant event number 218432 dated 10th of February of 2015, Laboratorios Farmacéuticos ROVI, S.A. (“ROVI” or the “Company”) informs that the Decentralised procedure used for the Company to submit, in twenty six countries of the European Union, the marketing authorization application of a low molecular weight heparin (biosimilar of enoxaparin) has been completed with positive outcome. In the mentioned Decentralised procedure, Germany has acted as Reference Member State (RMS). It has been initiated, therefore, the national phase of the registration process, which is expected to be completed with the granting by the competent local authorities of the marketing authorisation in each concerned country. This national phase could last from three to ten months. ROVI will continue to regularly update about the milestones considered relevant in this process of marketing authorisation as the schedule of the registration of the medicinal product progresses in each country. Thanking you in advance for your attention, I remain yours sincerely, D. Juan López-Belmonte Encina Chief Executive Officer Laboratorios Farmacéuticos ROVI, S.A

The release as fetched from its publisher. rovi.es ↗