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About us Complete the enquiry form on our Contact Us page Send an email: [email protected] Call us on: +31 20 808 4414 (EU) +1 646 381 0675 (US) +61 28 417 2910 (AUS) Others Available medicines Medicine approval The respective national and regional agencies, such as the Food and Drugs Administration (FDA) in the USA or the European Medical Authority (EMA) for the European Union assess these applications and make a decision on whether to approve new medicines

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Prior to 2013, all De Novo classifications resulted from a failure to obtain 510(k) clearance for the device due to a NSE determination

That said, the way semaglutide works with your blood sugar is a big part of why it helps with weight loss