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Friday, April 26, 2019

CHMP issues positive opinion on marketing of opioid dependence med

The Committee for Medicinal Products for Human Use, or CHMP, of the EMA adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Sixmo, intended for the treatment of opioid dependence. The applicant for this medicinal product is L. Molteni & C. dei Fratelli Alitti Societa di Esercizio S.p.A. On March 21, 2018, Titan Pharmaceuticals announced that it had entered into a definitive asset purchase, supply and support agreement with L. Molteni & C. dei F.lli Alitti Societa di Esercizio S.p.A. through which Molteni has acquired the European intellectual property related to Probuphine, including the Marketing Authorization Application under review by the European Medicines Agency, and will have the exclusive right to commercialize the Titan supplied Probuphine product in Europe, as well as certain countries of the Commonwealth of Independent States, the Middle East and North Africa.
https://thefly.com/landingPageNews.php?id=2898567

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