PRAC recommendations on safety signals: monthly overviews: Archive

2014

PRAC recommendations on signals adopted at the PRAC meeting of 1-4 December 2014

Adopted Reference Number: EMA/PRAC/734095/2014 Summary:

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).

PRAC recommendations on signals adopted at the PRAC meeting of 3-6 November 2014

Adopted Reference Number: EMA/PRAC/683212/2014 Summary:

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).

PRAC recommendations on signals adopted at the PRAC meeting of 6-9 October 2014

Adopted Reference Number: EMA/PRAC/618934/2014

PRAC recommendations on signals adopted at the PRAC meeting of 8-11 September 2014

Adopted Reference Number: EMA/PRAC/490498/2014 Summary:

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).

PRAC recommendations on signals adopted at the PRAC meeting of 7-10 July 2014

Adopted Reference Number: EMA/PRAC/425079/2014 Summary:

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).

PRAC recommendations on signals adopted at the PRAC meeting of 10-13 June 2014

Adopted Reference Number: EMA/PRAC/337405/2014

PRAC recommendations on signals adopted at the PRAC meeting of 5-8 May 2014

Adopted Reference Number: EMA/PRAC/272621/2014

PRAC recommendations on signals adopted at the PRAC meeting of 7-10 April 2014

Adopted Reference Number: EMA/PRAC/229812/2014

PRAC recommendations on signals adopted at the PRAC meeting of 3-6 March 2014

Adopted Reference Number: EMA/PRAC/144622/2014

PRAC recommendations on signals adopted at the PRAC meeting of 3-6 February 2014

Adopted Reference Number: EMA/PRAC/65788/2014

PRAC recommendations on signals adopted at the PRAC meeting of 6-9 January 2014

Adopted Reference Number: EMA/PRAC/25732/2014

PRAC recommendations on signals adopted at the PRAC meeting of 2-5 December 2013

Adopted Reference Number: EMA/PRAC/773133/2013 Summary:

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.

PRAC recommendations on signals adopted at the PRAC meeting of 4-7 November 2013

Adopted Reference Number: EMA/PRAC/693228/2013 Summary:

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.

PRAC recommendations on signals adopted at the PRAC meeting of 7-10 October 2013

Adopted Reference Number: EMA/PRAC/625262/2013

PRAC recommendations on signals adopted at the PRAC meeting of 2-5 September 2013

Adopted Reference Number: EMA/PRAC/550442/2013

PRAC signal recommendations requesting an update of the product information – September 2012 to July 2013

Adopted Reference Number: EMA/PRAC/720475/2013 Rev.1 Summary:

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.

2015

PRAC recommendations on signals adopted at the PRAC meeting of 30 November - 3 December 2015

Adopted Reference Number: EMA/PRAC/788914/2015 Summary:

PRAC recommendations on signals adopted at the PRAC meeting of 30 November - 3 December 2015

PRAC recommendations on signals adopted at the PRAC meeting of 3-6 November 2015

Adopted Reference Number: EMA/PRAC/711550/2015 Summary:

PRAC recommendations on signals adopted at the PRAC meeting of 3-6 November 2015

New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC

Adopted Reference Number: EMA/PRAC/711684/2015 Summary:

New product information wording: Extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC

PRAC recommendations on signals adopted at the PRAC meeting of 5-8 October 2015

Adopted Reference Number: EMA/PRAC/661789/2015 Summary:

PRAC recommendations on signals adopted at the PRAC meeting of 5-8 October 2015

New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC

Adopted Reference Number: EMA/PRAC/661880/2015

PRAC recommendations on signals adopted at the PRAC meeting of 7-10 September 2015

Adopted Reference Number: EMA/PRAC/590240/2015 Summary:

PRAC recommendations on signals adopted at the PRAC meeting of 7-10 September 2015

New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC

Reference Number: EMA/PRAC/590265/2015 Summary:

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.

PRAC recommendations on signals adopted at the PRAC meeting of 6-9 July 2015

Adopted Reference Number: EMA/PRAC/450903/2015 Summary:

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).

New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC

Adopted Reference Number: EMA/PRAC/450962/2015 Summary:

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.

PRAC recommendations on signals adopted at the PRAC meeting of 8-11 June 2015

Adopted Reference Number: EMA/PRAC/383371/2015

PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC

Adopted Reference Number: EMA/PRAC/277134/2015

PRAC recommendations on signals adopted at the PRAC meeting of 4-7 May 2015

Adopted Reference Number: EMA/PRAC/274321/2015

PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC

Adopted Reference Number: EMA/PRAC/239532/2015

PRAC recommendations on signals adopted at the PRAC meeting of 7-10 April 2015

Adopted Reference Number: EMA/PRAC/234960/2015 Summary:

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).

PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015

Adopted Reference Number: EMA/PRAC/194999/2015 Summary:

PRAC recommendations on signals for update of the product information adopted at the 9-12 March 2015 PRAC

PRAC recommendations on signals adopted at the PRAC meeting of 9-12 March 2015

Adopted Reference Number: EMA/PRAC/176901/2015 corr.

PRAC recommendations on signals adopted at the PRAC meeting of 9-12 February 2015

Adopted Reference Number: EMA/PRAC/107418/2015

PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015

Adopted Reference Number: EMA/PRAC/118045/2015 Summary:

PRAC recommendations on signals for update of the product information

PRAC recommendations on signals adopted at the PRAC meeting of 6-9 January 2015

Adopted Reference Number: EMA/PRAC/734433/2014 Corr. Summary:

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).

PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015

Adopted Reference Number: EMA/PRAC/62352/2015

2016

PRAC recommendations on signals adopted at the PRAC meeting of 11-14 January 2016

Adopted Reference Number: EMA/PRAC/1275/2016 Summary:

PRAC recommendations on signals adopted at the PRAC meeting of 11-14 January 2016

New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC

Adopted Reference Number: EMA/PRAC/1320/2016 Summary:

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).

PRAC recommendations on signals adopted at the PRAC meeting of 8-11 February 2016

Adopted Reference Number: EMA/PRAC/87046/2016 Summary:

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).

New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC

Adopted Reference Number: EMA/PRAC/87260/2016 Summary:

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.

PRAC recommendations on signals adopted at the PRAC meeting of 14-17 March 2016

Adopted Reference Number: EMA/PRAC/135876/2016 Summary:

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).

New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC

Adopted Reference Number: EMA/PRAC/136000/2016

PRAC recommendations on signals adopted at the PRAC meeting of 11-14 April 2016

Adopted Reference Number: EMA/PRAC/259909/2016

New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC

Adopted Reference Number: EMA/PRAC/259913/2016

PRAC recommendations on signals adopted at the PRAC meeting of 10-13 May 2016

Adopted Reference Number: EMA/PRAC/313187/2016

New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC

Adopted Reference Number: EMA/PRAC/313237/2016 Summary:

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.

PRAC recommendations on signals adopted at the PRAC meeting of 6-9 June 2016

Adopted Reference Number: EMA/PRAC/394327/2016 Summary:

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).

New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC

Reference Number: EMA/PRAC/400813/2016

PRAC recommendations on signals adopted at the PRAC meeting of 4-8 July 2016

Adopted Reference Number: EMA/PRAC/452657/2016

New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC

Reference Number: EMA/PRAC/452713/2016

PRAC recommendations on signals adopted at the PRAC meeting of 30 August-2 September 2016

Adopted Reference Number: EMA/PRAC/551805/2016

New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC

Reference Number: EMA/PRAC/551910/2016

PRAC recommendations on signals adopted at the PRAC meeting of 26-29 September 2016

Adopted Reference Number: EMA/PRAC/634818/2016 Summary:

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 26-29 September 2016 PRAC

Reference Number: EMA/PRAC/636169/2016 Summary:

New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC

PRAC recommendations on signals adopted at the PRAC meeting of 24-27 October 2016

Adopted Reference Number: EMA/PRAC/700146/2016

New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC

PRAC recommendations on signals adopted at the PRAC meeting of 28 November-1 December 2016

Adopted

New product information wording: extracts from PRAC recommendations on signals adopted at the 28 November-1 December 2016 PRAC

Reference Number: EMA/PRAC/740435/2016 Summary:

New product information wording: extracts from PRAC recommendations on signals adopted at the 28 November-1 December 2016 PRAC

2017

PRAC recommendations on signals adopted at the PRAC meeting of 9-12 January 2017

Adopted Reference Number: EMA/PRAC/5653/2017

New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 January 2017 PRAC

Adopted Reference Number: EMA/PRAC/5725/2017

PRAC recommendations on signals adopted at the PRAC meeting of 6-9 February 2017

Adopted Reference Number: EMA/PRAC/68642/2017

New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 February 2017 PRAC

Adopted Reference Number: EMA/PRAC/68687/2017

PRAC recommendations on signals adopted at the PRAC meeting of 6-9 March 2017

Adopted Reference Number: EMA/PRAC/146565/2017

New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 March 2017 PRAC

Reference Number: EMA/PRAC/146563/2017 Summary:

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.

PRAC recommendations on signals adopted at the PRAC meeting of 3-6 April 2017

Adopted Reference Number: EMA/PRAC/221998/2017

New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 April 2017 PRAC

Reference Number: EMA/PRAC/221996/2017 Summary:

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.

PRAC recommendations on signals adopted at the PRAC meeting of 2-5 May 2017

Adopted Reference Number: EMA/PRAC/252869/2017

New product information wording: extracts from PRAC recommendations on signals adopted at the 2-5 May 2017 PRAC

Reference Number: EMA/PRAC/252868/2017

PRAC recommendations on signals adopted at the 6-9 June 2017 PRAC meeting

Adopted Reference Number: EMA/PRAC/337620/2017 Summary:

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 6-9 June 2017 PRAC

Reference Number: EMA/PRAC/337624/2017 Summary:

New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2017 PRAC

PRAC recommendations on signals adopted at the 3-6 July 2017 PRAC meeting

Adopted Reference Number: EMA/PRAC/406987/2017

New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 July 2017 PRAC

Reference Number: EMA/PRAC/406976/2017

PRAC recommendations on signals adopted at the 29 August - 1 September 2017 PRAC meeting

Adopted Reference Number: EMA/PRAC/407007/2017 Corr.1

New product information wording: extracts from PRAC recommendations on signals adopted at the 29 August-1 September 2017 PRAC

Reference Number: EMA/PRAC/600977/2017 Corr.1

PRAC recommendations on signals adopted at the 25-29 September 2017 PRAC meeting

Adopted Reference Number: EMA/PRAC/610975/2017

New product information wording: extracts from PRAC recommendations on signals adopted at the 25-29 September 2017 PRAC

Reference Number: EMA/PRAC/610988/2017 Summary:

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.

PRAC recommendations on signals adopted at the 23-26 October 2017 PRAC meeting

Adopted Reference Number: EMA/PRAC/610976/2017 Summary:

PRAC recommendations on signals adopted at the 23-26 October 2017 PRAC meeting

PRAC recommendations on signals adopted at the PRAC meeting of 27-30 November 2017

Adopted Reference Number: EMA/PRAC/610978/2017 Summary:

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 25-30 November 2017 PRAC

Reference Number: EMA/PRAC/611010/2017

2018

PRAC recommendations on signals adopted at the PRAC meeting of 8-11 January 2018 meeting

Adopted Reference Number: EMA/PRAC/8429/2018 Corr Summary:

PRAC recommendations on signals adopted at the PRAC meeting of 8-11 January 2018 meeting

New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 January 2018 PRAC

Reference Number: EMA/PRAC/8436/2018 Summary:

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.

PRAC recommendations on signals adopted at the 5-8 February 2018 PRAC meeting

Adopted Reference Number: EMA/PRAC/59224/2018 Summary:

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.

New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 February 2018 PRAC

Reference Number: EMA/PRAC/59227/2018

PRAC recommendations on signals adopted at the 5-8 March 2018 PRAC meeting

Adopted Reference Number: EMA/PRAC/136563/2018

New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 March 2018 PRAC

Reference Number: EMA/PRAC/136578/2018

PRAC recommendations on signals adopted at the 9-12 April 2018 PRAC meeting

Adopted Reference Number: EMA/PRAC/211744/2018

New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 April 2018 PRAC

Reference Number: EMA/PRAC/211550/2018

PRAC recommendations on signals adopted at the 14-17 May 2018 PRAC meeting

Adopted Reference Number: EMA/PRAC/287231/2018

New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 May 2018 PRAC

Reference Number: EMA/PRAC/287233/2018

PRAC recommendations on signals adopted at the 11-14 June 2018 PRAC meeting

Adopted Reference Number: EMA/PRAC/397086/2018

New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 June 2018 PRAC

Reference Number: EMA/PRAC/397088/2018

PRAC recommendations on signals adopted at the 9-12 July 2018 PRAC meeting

Adopted Reference Number: EMA/PRAC/414645/2018 Summary:

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.

New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 July 2018 PRAC

Adopted Reference Number: EMA/PRAC/414649/2018

PRAC recommendations on signals adopted at the 3-6 September 2018 PRAC meeting

Adopted Reference Number: EMA/PRAC/595691/2018

New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 September 2018 PRAC

Reference Number: EMA/PRAC/595696/2018

PRAC recommendations on signals adopted at the 1-4 October 2018 PRAC meeting

Adopted Reference Number: EMA/PRAC/689235/2018

New product information wording: extracts from PRAC recommendations on signals adopted at the 1-4 October 2018 PRAC

Reference Number: EMA/PRAC/689237/2018

PRAC recommendations on signals adopted at the 29-31 October 2018 PRAC meeting

Adopted Reference Number: EMA/PRAC/758152/2018

New product information wording: extracts from PRAC recommendations on signals adopted at the 29-31 October 2018 PRAC

Reference Number: EMA/PRAC/758155/2018

PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC meeting

Adopted Reference Number: EMA/PRAC/826440/2018 Summary:

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/595696/2018 Summary:

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.