Each month, the European Medicines Agency publishes an overview listing all safety signals discussed during the latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting and the recommendations given for each of them. The overview includes PRAC recommendations for centrally and nationally authorised medicines.
PRAC recommendations for regulatory action (i.e. amendment of the product information) are submitted to:
- the Committee for Medicinal Products for Human Use (CHMP), for endorsement, if the signal concerns a centrally authorised medicine. At the time of publication, the PRAC recommendations have been endorsed by the CHMP;
- the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), for information, if the signal concerns a nationally authorised medicine. It is the responsibility of the medicines regulatory authorities in the Member States to oversee that these PRAC recommendations are adhered to.
Marketing-authorisation holders are expected to take action according to the recommendations. They should monitor the information on this page regularly to keep informed about the PRAC recommendations concerning their products.
The presence of a safety signal does not mean that a medicine has caused the reported adverse event. The adverse event could be a symptom of another illness or caused by another medicine taken by the patient.
The overview of PRAC recommendations is published after each month's CHMP and CMDh meeting. The first list was published in October 2013 and lists the recommendations from the September 2013 PRAC meeting. A cumulative list of all signals discussed at the PRAC since September 2012 is also available below.
Starting from the January 2015 PRAC meeting, the Agency now publishes recommendations for updates of product information translated into all official European Union (EU) languages.
The Agency publishes these translations in all official EU languages, as well as Norwegian and Icelandic, in the table below after review of their quality by the national regulatory authorities in EU Member States.
Marketing-authorisation holders can use these translations to update their product information.
The Agency expects this initiative to accelerate the implementation of changes to product information and to ensure consistency across EU countries, thus leading to better information for patients on their medicines.
For more information on how safety signals are assessed in the EU, see:
PRAC recommendations on safety signals
PRAC recommendations on signals adopted at the 5-8 February 2024 PRAC meeting
PRAC recommendations on signals adopted at the 8-11 January 2024 PRAC meeting
New product information wording – Extracts from PRAC recommendations on signals adopted at the 8-11 January 2024 PRAC
PRAC recommendations on signals adopted at the 27-30 November 2023 PRAC meeting
New product information wording – Extracts from PRAC recommendations on signals adopted at the 27-30 November 2023 PRAC
PRAC recommendations on signals adopted at the 23-26 October 2023 PRAC
New product information wording – Extracts from PRAC recommendations on signals adopted at the 23-26 October PRAC
PRAC recommendations on signals adopted at the 25-28 September 2023 PRAC
New product information wording: extracts from PRAC recommendations on signals adopted at the 25-28 September 2023 PRAC
PRAC recommendations on signals adopted at the 28-31 August 2023 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 28-31 August 2023 PRAC meeting
PRAC recommendations on signals adopted at the 3-6 July 2023 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 July 2023 PRAC meeting
PRAC recommendations on signals adopted at the 5-8 June 2023 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 June 2023 PRAC meeting
PRAC recommendations on signals adopted at the 10-12 May 2023 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-12 May 2023 PRAC meeting
PRAC recommendations on signals adopted at the 11-14 April 2023 PRAC meeting
PRAC recommendations on signals adopted at the 13-16 March 2023 PRAC meeting
New product information wording : extracts from PRAC recommendations on signals adopted at the 13-16 March 2023 PRAC
PRAC recommendations on signals adopted at the 6-9 February 2023 PRAC meeting
New product information wording : extracts from PRAC recommendations on signals adopted at the 6-9 February 2023 PRAC meeting
PRAC recommendations on signals adopted at the 9-12 January 2023 PRAC meeting
New product information wording : extracts from PRAC recommendations on signals adopted at the 9-12 January 2023 PRAC meeting
PRAC recommendations on signals adopted at the 28 November - 1 December 2022 PRAC meeting
PRAC recommendations on signals adopted at the 24-27 October 2022 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2022 PRAC meeting
PRAC recommendations on signals adopted at the 26-29 September 2022 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2022 PRAC meeting
PRAC recommendations on signals adopted at the 29 August - 1 September 2022 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 29 August - 1 September 2022 PRAC
PRAC recommendations on signals adopted at the 4-7 July 2022 PRAC meeting
PRAC recommendations on signals adopted at the 7-10 June 2022 PRAC meeting
PRAC recommendations on signals adopted at the 2-5 May 2022 PRAC meeting
PRAC recommendations on signals adopted at the 4-7 April 2022 PRAC meeting
PRAC recommendations on signals adopted at the 7-10 March 2022 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 March 2022 PRAC
PRAC recommendations on signals adopted at the 7-10 February 2022 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 February 2022 PRAC
PRAC recommendations on signals adopted at the 10-13 January 2022 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 January 2022 PRAC
PRAC recommendations on signals adopted at the 29 November-2 December 2021 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 29 November - 2 December 2021 PRAC meeting
PRAC recommendations on signals adopted at the 25-28 October 2021 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 25-28 October 2021 PRAC meeting
PRAC recommendations on signals adopted at the 27-30 September 2021 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals - Part 2 - adopted at the 27-30 September 2021 PRAC
New product information wording – Extracts from PRAC recommendations on signals – Part 1 – Vaxzevria - adopted at the PRAC meeting of 27-30 September 2021
PRAC recommendations on signals adopted at the 30 August - 2 September 2021 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August - 2 September 2021 PRAC
PRAC recommendations on signals adopted at the 5-8 July 2021 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 July 2021 PRAC meeting
PRAC recommendations on signals adopted at the 7-10 June 2021 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals - Part 2 - adopted at the PRAC meeting of 7-10 June 2021
New product information wording: extracts from PRAC recommendations on signals - Part 1 - adopted at the PRAC meeting of 7-10 June 2021
PRAC recommendations on signals adopted at the 3-6 May 2021 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 May 2021 PRAC meeting
PRAC recommendations on signals adopted at the 6-9 April 2021 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 April 2021 PRAC meeting
PRAC recommendations on signals adopted at the 8-11 March 2021 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 March 2021 PRAC
Signal assessment report on embolic and thrombotic events (SMQ) with COVID-19 Vaccine (ChAdOx1-S [recombinant]) – COVID-19 Vaccine AstraZeneca (Other viral vaccines)
PRAC recommendations on signals adopted at the 8-11 February 2021 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2021 PRAC
PRAC recommendations on signals adopted at the 11-14 January 2021 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2021 PRAC
PRAC recommendations on signals adopted at the 23-26 November 2020 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 23-26 November 2020 PRAC
PRAC recommendations on signals adopted at the 26-29 October 2020 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 October 2020 PRAC
PRAC recommendations on signals adopted at the 28 September-1 October 2020 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 28 September-1 October 2020 PRAC
PRAC recommendations on signals adopted at the 31 August-3 September 2020 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 31 August-3 September 2020 PRAC
PRAC recommendations on signals adopted at the 6-9 July 2020 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2020 PRAC
PRAC recommendations on signals adopted at the 8-11 June 2020 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 June 2020 PRAC
PRAC recommendations on signals adopted at the 11-14 May 2020 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 May 2020 PRAC
PRAC recommendations on signals adopted at the 14-17 April 2020 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 April 2020 PRAC
PRAC recommendations on signals adopted at the 9-12 March 2020 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 March 2020 PRAC
PRAC recommendations on signals adopted at the 10-13 February 2020 PRAC meeting
PRAC recommendations on signals adopted at the 13-16 January 2020 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 13-16 January 2020 PRAC meeting
PRAC recommendations on signals adopted at the 25-28 November 2019 PRAC meeting
PRAC recommendations on signals adopted at the 28-31 October 2019 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 28-31 October 2019 PRAC
PRAC recommendations on signals adopted at the 30 September-3 October 2019 PRAC meeting
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 30 September-3 October 2019
PRAC recommendations on signals adopted at the 2-5 September 2019 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 2-5 September 2019 PRAC meeting
PRAC recommendations on signals adopted at the 8-11 July 2019 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 July 2019 PRAC
Updated signal assessment report on birth defects following in-utero exposure during the first trimester of pregnancy arising from recent publications with ondansetr
PRAC recommendations on signals adopted at the 11-14 June 2019 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 June 2019 PRAC
PRAC recommendations on signals adopted at the 13-16 May 2019 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 13-16 May 2019 PRAC
PRAC recommendations on signals adopted at the 8-11 April 2019 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 April 2019 PRAC
PRAC recommendations on signals adopted at the 12-15 March 2019 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 12-15 March 2019 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 11-14 February 2019
PRAC recommendations on signals adopted at the 14-17 January 2019 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 January 2019 PRAC
PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC
PRAC recommendations on signals adopted at the 29-31 October 2018 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 29-31 October 2018 PRAC
PRAC recommendations on signals adopted at the 1-4 October 2018 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 1-4 October 2018 PRAC
PRAC recommendations on signals adopted at the 3-6 September 2018 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 September 2018 PRAC
PRAC recommendations on signals adopted at the 9-12 July 2018 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 July 2018 PRAC
PRAC recommendations on signals adopted at the 11-14 June 2018 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 June 2018 PRAC
PRAC recommendations on signals adopted at the 14-17 May 2018 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 May 2018 PRAC
PRAC recommendations on signals adopted at the 9-12 April 2018 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 April 2018 PRAC
PRAC recommendations on signals adopted at the 5-8 March 2018 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 March 2018 PRAC
PRAC recommendations on signals adopted at the 5-8 February 2018 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 February 2018 PRAC
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
PRAC recommendations on signals adopted at the PRAC meeting of 27-30 November 2017
New product information wording: extracts from PRAC recommendations on signals adopted at the 25-30 November 2017 PRAC
PRAC recommendations on signals adopted at the 23-26 October 2017 PRAC meeting
PRAC recommendations on signals adopted at the 25-29 September 2017 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 25-29 September 2017 PRAC
PRAC recommendations on signals adopted at the 29 August - 1 September 2017 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 29 August-1 September 2017 PRAC
PRAC recommendations on signals adopted at the 3-6 July 2017 PRAC meeting
New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 July 2017 PRAC
PRAC recommendations on signals adopted at the 6-9 June 2017 PRAC meeting
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 PRAC meeting of 2-5 May 2017
New product information wording: extracts from PRAC recommendations on signals adopted at the 2-5 May 2017 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 3-6 April 2017
New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 April 2017 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 March 2017
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 March 2017 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 February 2017
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 February 2017 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 9-12 January 2017
New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 January 2017 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 28 November-1 December 2016
New product information wording: extracts from PRAC recommendations on signals adopted at the 28 November-1 December 2016 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 24-27 October 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 26-29 September 2016
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 30 August-2 September 2016
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 4-8 July 2016
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 June 2016
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 10-13 May 2016
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 11-14 April 2016
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 14-17 March 2016
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 8-11 February 2016
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC
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
PRAC recommendations on signals adopted at the PRAC meeting of 30 November - 3 December 2015
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 3-6 November 2015
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
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
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 July 2015
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 8-11 June 2015
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 4-7 May 2015
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC
PRAC recommendations on signals adopted at the PRAC meeting of 7-10 April 2015
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015
PRAC recommendations on signals adopted at the PRAC meeting of 9-12 March 2015
PRAC recommendations on signals adopted at the PRAC meeting of 9-12 February 2015
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 January 2015
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015
Expected publication dates of PRAC recommendations on safety signals
Expected publication dates of PRAC recommendations on safety signals
List of safety signals discussed since September 2012
List of signals discussed at PRAC since September 2012