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Inpharma 1573 - 3 Feb 2007 Other EU regulatory news The CHMP of the EMEA has issued a positive opinion recommending the approval of sodium oxybate [Xyrem; UCB] in the treatment of narcolepsy with cataplexy in adults in the EU. 1 Merck & Co’s sitagliptin [Januvia] has received a positive opinion from the CHMP for use in the treatment of patients with type 2 diabetes mellitus. 2 1. UCB. European Medicines Agency Adopts Positive Opinion Recommending Approval of Xyrem(R) for the Treatment of Narcolepsy with Cataplexy in Adult Patients. Media Release : 25 Jan 2007. Available from: URL: http://www.ucb- group.com. 2. Merck & Co Inc. JANUVIA, First in New Class of Oral Treatments Known as DPP-4 Inhibitors, Recommended for Approval for the Treatment of Type 2 Diabetes in the European Union. Media Release : 26 Jan 2007. Available from: URL: http://www.merck.com. 801069408 1 Inpharma 3 Feb 2007 No. 1573 1173-8324/10/1573-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Other EU regulatory news

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Page 1: Other EU regulatory news

Inpharma 1573 - 3 Feb 2007

Other EU regulatory newsThe CHMP of the EMEA has issued a positive opinion

recommending the approval of sodium oxybate[Xyrem; UCB] in the treatment of narcolepsy withcataplexy in adults in the EU.1

Merck & Co’s sitagliptin [Januvia] has received apositive opinion from the CHMP for use in the treatmentof patients with type 2 diabetes mellitus.2

1. UCB. European Medicines Agency Adopts Positive Opinion RecommendingApproval of Xyrem(R) for the Treatment of Narcolepsy with Cataplexy in AdultPatients. Media Release : 25 Jan 2007. Available from: URL: http://www.ucb-group.com.

2. Merck & Co Inc. JANUVIA™, First in New Class of Oral Treatments Knownas DPP-4 Inhibitors, Recommended for Approval for the Treatment of Type 2Diabetes in the European Union. Media Release : 26 Jan 2007. Available from:URL: http://www.merck.com.

801069408

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Inpharma 3 Feb 2007 No. 15731173-8324/10/1573-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved