Transcription of PRAC recommendations on signals
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PRAC recommendations on signals
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. 2 August 20211 EMA/PRAC/380226/2021 Corr2 3 Pharmacovigilance Risk Assessment Committee (PRAC) prac recommendations on signals Adopted at the 5-8 July 2021 PRAC meeting This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 5-8 July 2021 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT]4 reference numbers). prac recommendations to provide supplementary information are directly actionable by the concerned marketing authorisation holders (MAHs).
Jul 08, 2021 · PRAC recommendations on signals EMA/PRAC/380226/2021 Page 3/15 1. Recommendations for update of the product information 5 1.1. Donepezil – Cardiac conduction disorders including QT prolongation and Torsade de Pointes Authorisation procedure Non-centralised EPITT No 19667 PRAC rapporteur(s) Martin Huber (DE) Date of adoption 8 July 2021
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