This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 1-4 December 2014 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT] reference numbers).
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 3-6 November 2014 (including the signal European Pharmacovigilance Issues Tracking Tool (EPITT) reference numbers).
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 8-11 September 2014 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT]1 reference numbers).
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 7-10 July 2014 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT] reference numbers).
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 2-5 December 2013.
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 4-7 November 2013.
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) requesting an update of the product information for the period September 2012 - July 2013.
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC
Reference Number: EMA/PRAC/590265/2015Summary:
The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals’ which contains the whole text of the PRAC recommendations for product information update.
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 6-9 July 2015 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT]1 reference numbers).
The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals’ which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 7-10 April 2015 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT]1 reference numbers).
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 6-9 January 2015 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT] reference numbers).
The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals’ which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals. It can be found here (in English only).
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 8-11 February 2016 (including the signal European Pharmacovigilance Issues Tracking Tool reference numbers).
The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals’ which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 14-17 March 2016 (including the signal European Pharmacovigilance Issues Tracking Tool reference numbers).
The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals’ which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 6-9 June 2016 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT]1 reference numbers).
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 26-29 September 2016 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT] reference numbers).
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 March 2017 PRAC
Reference Number: EMA/PRAC/146563/2017Summary:
The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals’ which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.
New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 April 2017 PRAC
Reference Number: EMA/PRAC/221996/2017Summary:
The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals’ which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 6-9 June 2017 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT]1 reference numbers).
New product information wording: extracts from PRAC recommendations on signals adopted at the 25-29 September 2017 PRAC
Reference Number: EMA/PRAC/610988/2017Summary:
The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals’ which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 27-30 November 2017.
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 January 2018 PRAC
Reference Number: EMA/PRAC/8436/2018Summary:
The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals’ which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.
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 February 2018.
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 9-12 July 2018.
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 26-29 November 2018 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT]2 reference numbers).
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC
Reference Number: EMA/PRAC/595696/2018Summary:
The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals’ which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.