PRAC recommendations on safety signals
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:
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Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1) (PDF/283.21 KB)
Adopted
First published: 25/06/2012
Last updated: 12/10/2017
Legal effective date: 22/11/2017
EMA/827661/2011 -
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Questions and answers on signal management (PDF/336.17 KB)
First published: 04/10/2013
Last updated: 15/01/2021
EMA/261758/2013 Rev 4*
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PRAC recommendations on signals for update of the product information adopted at the 23-26 October 2023 PRAC (PDF/199.17 KB) (new)
Adopted
First published: 20/11/2023
EMA/PRAC/477437/2023 -
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New product information wording – Extracts from PRAC recommendations on signals adopted at the 23-26 October PRAC (PDF/165.6 KB) (new)
First published: 20/11/2023
EMA/PRAC/477437/2023 -
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PRAC recommendations on signals adopted at the 25-28 September 2023 PRAC (PDF/146.79 KB)
Adopted
First published: 23/10/2023
EMA/PRAC/416575/2023 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 25-28 September 2023 PRAC (PDF/158.31 KB)
Adopted
First published: 23/10/2023
EMA/PRAC/416581/2023 -
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PRAC recommendations on signals adopted at the 28-31 August 2023 PRAC meeting (PDF/194.43 KB)
Adopted
First published: 25/09/2023
EMA/PRAC/359902/2023 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 28-31 August 2023 PRAC meeting (PDF/165.22 KB)
Adopted
First published: 25/09/2023
EMA/PRAC/359903/2023 -
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PRAC recommendations on signals adopted at the 3-6 July 2023 PRAC meeting (PDF/203.33 KB)
Adopted
First published: 31/07/2023
EMA/PRAC/294541/2023 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 July 2023 PRAC meeting (PDF/208.23 KB)
Adopted
First published: 31/07/2023
EMA/PRAC/294581/2023 -
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PRAC recommendations on signals adopted at the 5-8 June 2023 PRAC meeting (PDF/213.41 KB)
Adopted
First published: 03/07/2023
EMA/PRAC/248309/2023 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 June 2023 PRAC meeting (PDF/159.72 KB)
Adopted
First published: 03/07/2023
EMA/PRAC/248310/2023 -
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PRAC recommendations on signals adopted at the 10-12 May 2023 PRAC meeting (PDF/269.98 KB)
Adopted
First published: 05/06/2023
EMA/PRAC/207872/2023 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 10-12 May 2023 PRAC meeting (PDF/180.72 KB)
Adopted
First published: 05/06/2023
EMA/PRAC/207873/2023 -
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PRAC recommendations on signals adopted at the 11-14 April 2023 PRAC meeting (PDF/155.71 KB)
Adopted
First published: 08/05/2023
EMA/PRAC/164741/2023 -
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PRAC recommendations on signals adopted at the 13-16 March 2023 PRAC meeting (PDF/217.48 KB)
Adopted
First published: 11/04/2023 -
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New product information wording : extracts from PRAC recommendations on signals adopted at the 13-16 March 2023 PRAC (PDF/195.63 KB)
Adopted
First published: 11/04/2023
EMA/PRAC/103894/2023 -
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PRAC recommendations on signals adopted at the 6-9 February 2023 PRAC meeting (PDF/211.21 KB)
Adopted
First published: 06/03/2023 -
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New product information wording : extracts from PRAC recommendations on signals adopted at the 6-9 February 2023 PRAC meeting (PDF/165.1 KB)
Adopted
First published: 06/03/2023
EMA/PRAC/74665/2023 -
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PRAC recommendations on signals adopted at the 9-12 January 2023 PRAC meeting (PDF/227.11 KB)
Adopted
First published: 06/02/2023
Last updated: 23/06/2023
EMA/PRAC/4770/2023 -
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New product information wording : extracts from PRAC recommendations on signals adopted at the 9-12 January 2023 PRAC meeting (PDF/201 KB)
Adopted
First published: 06/02/2023
EMA/PRAC/4771/2023 -
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PRAC recommendations on signals adopted at the 28 November - 1 December 2022 PRAC meeting (PDF/159.21 KB)
Adopted
First published: 05/01/2023
EMA/PRAC/900558/2022 -
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PRAC recommendations on signals adopted at the 24-27 October 2022 PRAC meeting (PDF/288.84 KB)
Adopted
First published: 21/11/2022
EMA/PRAC/845793/2022 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2022 PRAC meeting (PDF/217.94 KB)
Adopted
First published: 21/11/2022
Last updated: 07/12/2022
EMA/PRAC/845794/2022 -
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PRAC recommendations on signals adopted at the 26-29 September 2022 PRAC meeting (PDF/236.53 KB)
Adopted
First published: 24/10/2022
EMA/PRAC/781568/2022 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2022 PRAC meeting (PDF/202.61 KB)
Adopted
First published: 24/10/2022
EMA/PRAC/781569/2022 -
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PRAC recommendations on signals adopted at the 29 August - 1 September 2022 PRAC meeting (PDF/200.74 KB)
Adopted
First published: 26/09/2022
EMA/PRAC/699721/2022 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 29 August - 1 September 2022 PRAC (PDF/162.15 KB)
Adopted
First published: 26/09/2022
EMA/PRAC/699722/2022 -
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PRAC recommendations on signals adopted at the 4-7 July 2022 PRAC meeting (PDF/160.13 KB)
Adopted
First published: 01/08/2022
EMA/PRAC/610990/2022 -
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PRAC recommendations on signals adopted at the 7-10 June 2022 PRAC meeting (PDF/154.79 KB)
Adopted
First published: 04/07/2022
EMA/PRAC/407574/2022 -
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PRAC recommendations on signals adopted at the 2-5 May 2022 PRAC meeting (PDF/136.03 KB)
Adopted
First published: 30/05/2022
EMA/PRAC/242991/2022 -
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PRAC recommendations on signals adopted at the 4-7 April 2022 PRAC meeting (PDF/145.74 KB)
Adopted
First published: 02/05/2022
EMA/PRAC/201501/2022 -
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PRAC recommendations on signals adopted at the 7-10 March 2022 PRAC meeting (PDF/317.17 KB)
Adopted
First published: 04/04/2022
EMA/PRAC/139810/2022 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 March 2022 PRAC (PDF/271.85 KB)
Adopted
First published: 04/04/2022
Last updated: 18/07/2022
EMA/PRAC/139811/2022 Corr. -
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PRAC recommendations on signals adopted at the 7-10 February 2022 PRAC meeting (PDF/229.36 KB)
Adopted
First published: 07/03/2022
EMA/PRAC/75386/2022 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 February 2022 PRAC (PDF/169.92 KB)
Adopted
First published: 07/03/2022
EMA/PRAC/75387/2022 -
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PRAC recommendations on signals adopted at the 10-13 January 2022 PRAC meeting (PDF/228.07 KB)
Adopted
First published: 07/02/2022
EMA/PRAC/13254/2022 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 January 2022 PRAC (PDF/190.89 KB)
Adopted
First published: 07/02/2022
EMA/PRAC/13256/2022 -
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PRAC recommendations on signals adopted at the 29 November-2 December 2021 PRAC meeting (PDF/249.21 KB)
Adopted
First published: 06/01/2022
EMA/PRAC/683817/2021 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 29 November - 2 December 2021 PRAC meeting (PDF/161.49 KB)
Adopted
First published: 06/01/2022
EMA/PRAC/683818/2021 -
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PRAC recommendations on signals adopted at the 25-28 October 2021 PRAC meeting (PDF/247.24 KB)
Adopted
First published: 22/11/2021
Last updated: 10/12/2021
EMA/PRAC/605613/2021 1 Corr2 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 25-28 October 2021 PRAC meeting (PDF/212.86 KB)
Adopted
First published: 22/11/2021
EMA/PRAC/605615/2021 -
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PRAC recommendations on signals adopted at the 27-30 September 2021 PRAC meeting (PDF/350.7 KB)
Adopted
First published: 26/10/2021
EMA/PRAC/540066/2021 -
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New product information wording: extracts from PRAC recommendations on signals - Part 2 - adopted at the 27-30 September 2021 PRAC (PDF/175.48 KB)
Adopted
First published: 26/10/2021
EMA/PRAC/548106/2021 -
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New product information wording – Extracts from PRAC recommendations on signals – Part 1 – Vaxzevria - adopted at the PRAC meeting of 27-30 September 2021 (PDF/199.55 KB)
Adopted
First published: 08/10/2021
EMA/PRAC/540071/2021 -
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PRAC recommendations on signals adopted at the 30 August - 2 September 2021 PRAC meeting (PDF/229.8 KB)
Adopted
First published: 27/09/2021 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August - 2 September 2021 PRAC (PDF/187.73 KB)
Adopted
First published: 27/09/2021
EMA/PRAC/468916/2021 -
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PRAC recommendations on signals adopted at the 5-8 July 2021 PRAC meeting (PDF/315.1 KB)
Adopted
First published: 02/08/2021
EMA/PRAC/380226/2021 Corr. 3 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 July 2021 PRAC meeting (PDF/241.88 KB)
Adopted
First published: 02/08/2021
Last updated: 26/10/2021
EMA/PRAC/380228/2021 Corr. 2 -
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PRAC recommendations on signals adopted at the 7-10 June 2021 PRAC meeting (PDF/418.49 KB)
Adopted
First published: 05/07/2021
EMA/PRAC/319259/2021 -
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New product information wording: extracts from PRAC recommendations on signals - Part 2 - adopted at the PRAC meeting of 7-10 June 2021 (PDF/347.41 KB)
Adopted
First published: 05/07/2021
EMA/PRAC/333370/2021 -
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New product information wording: extracts from PRAC recommendations on signals - Part 1 - adopted at the PRAC meeting of 7-10 June 2021 (PDF/141.28 KB)
Adopted
First published: 22/06/2021
EMA/PRAC/319262/2021 -
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PRAC recommendations on signals adopted at the 3-6 May 2021 PRAC meeting (PDF/373.36 KB)
Adopted
First published: 31/05/2021
Last updated: 26/08/2021
EMA/PRAC/250777/2021 Corr 2 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 May 2021 PRAC meeting (PDF/252.75 KB)
Adopted
First published: 31/05/2021
Last updated: 26/08/2021
EMA/PRAC/250778/2021 Corr 2 -
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PRAC recommendations on signals adopted at the 6-9 April 2021 PRAC meeting (PDF/284.12 KB)
Adopted
First published: 03/05/2021
EMA/PRAC/199751/2021 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 April 2021 PRAC meeting (PDF/194.49 KB)
First published: 03/05/2021
EMA/PRAC/219605/2021 -
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PRAC recommendations on signals adopted at the 8-11 March 2021 PRAC meeting (PDF/267.05 KB)
Adopted
First published: 06/04/2021
EMA/PRAC/146285/2021 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 March 2021 PRAC (PDF/179.78 KB)
Adopted
First published: 06/04/2021
EMA/PRAC/146288/2021 -
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Signal assessment report on embolic and thrombotic events (SMQ) with COVID-19 Vaccine (ChAdOx1-S [recombinant]) – COVID-19 Vaccine AstraZeneca (Other viral vaccines) (PDF/915.94 KB)
Adopted
First published: 31/03/2021
EMA/PRAC/157045/2021 -
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PRAC recommendations on signals adopted at the 8-11 February 2021 PRAC meeting (PDF/179.88 KB)
Adopted
First published: 08/03/2021
EMA/PRAC/82059/2021 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2021 PRAC (PDF/159.28 KB)
Adopted
First published: 08/03/2021
EMA/PRAC/82060/2021 -
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PRAC recommendations on signals adopted at the 11-14 January 2021 PRAC meeting (PDF/262.78 KB)
Adopted
First published: 08/02/2021
EMA/PRAC/19647/2021 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2021 PRAC (PDF/208.9 KB)
Adopted
First published: 08/02/2021
EMA/PRAC/19650/2021 -
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PRAC recommendations on signals adopted at the 23-26 November 2020 PRAC meeting (PDF/319.34 KB)
Adopted
First published: 06/01/2021
EMA/PRAC/630091/2020 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 23-26 November 2020 PRAC (PDF/210.69 KB)
Adopted
First published: 06/01/2021
EMA/PRAC/654443/2020 -
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PRAC recommendations on signals adopted at the 26-29 October 2020 PRAC meeting (PDF/289.9 KB)
Adopted
First published: 23/11/2020
Last updated: 06/07/2021
EMA/PRAC/570588/2020 Corr.3 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 October 2020 PRAC (PDF/211.03 KB)
Adopted
First published: 23/11/2020
EMA/PRAC/592306/2020 -
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PRAC recommendations on signals adopted at the 28 September-1 October 2020 PRAC meeting (PDF/280.39 KB)
Adopted
First published: 26/10/2020
EMA/PRAC/513083/2020 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 28 September-1 October 2020 PRAC (PDF/210.56 KB)
Adopted
First published: 26/10/2020
EMA/PRAC/513093/2020 -
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PRAC recommendations on signals adopted at the 31 August-3 September 2020 PRAC meeting (PDF/307.61 KB)
Adopted
First published: 28/09/2020
EMA/PRAC/458924/2020 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 31 August-3 September 2020 PRAC (PDF/252.27 KB)
Adopted
First published: 28/09/2020
EMA/PRAC/458930/2020 -
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PRAC recommendations on signals adopted at the 6-9 July 2020 PRAC meeting (PDF/248.18 KB)
Adopted
First published: 03/08/2020
EMA/PRAC/367621/2020 -
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New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2020 PRAC (PDF/190.42 KB)
Adopted
First published: 03/08/2020
EMA/PRAC/367622/2020 -
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PRAC recommendations on signals adopted at the 8-11 June 2020 PRAC meeting (PDF/264.72 KB)
Adopted
First published: 06/07/2020
EMA/PRAC/311314/2020 -
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