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Haitina T, Lindblom J, Renstrm T

Hybye C : Five-years growth hormone (GH) treatment in adults with Prader-Willi syndrome

Most of the delay was due to clock stops arising from requests for clarification during the review process, and also the time lapse about 90 days on average between a new drug receiving a positive opinion from the EMAs key body, the Committee for Medicinal Products for Human Use (CHMP) and final approval being granted by the European Commission (Br J Clin Pharmacol 2013, 76:369411)

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