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. 2019 Dec 6;107(3):521–529. doi: 10.1002/cpt.1678

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© 2019 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

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Outcomes of signals prioritized and analyzed at the Pharmacovigilance Risk Assessment Committee in the past 6 years. (a) Per year (b) September 2012 to June 2018. Note for a, 2012 data is merged with 2013 due to the low numbers. PASS, Post Authorization Safety Study; PI, Product Information; PSUR, Periodic Safety Update Report; PSUSA, Periodic Safety Update Single Assessment; Referral, in accordance with the Articles 31 and 107i of Directive 2001/83/EC(4) and Article 20 of Regulation (EC) No. 726/2004; RMP, Risk Management Plan.