Pharmacovigilance Risk Assessment Committee (PRAC): 25-29 September 2017
Date:
25/09/2017 to 29/09/2017
Location:
European Medicines Agency, London, UK
The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use.
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Minutes of the PRAC meeting 25-29 September 2017 (PDF/1 MB)
Adopted
First published: 24/11/2017
Last updated: 24/11/2017
EMA/PRAC/782068/2017 -
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Agenda - PRAC draft agenda of meeting 25-29 September 2017 (PDF/497.54 KB)
Draft
First published: 25/09/2017
Last updated: 25/09/2017
EMA/PRAC/634126/2017 -
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Agenda - Public hearing: Valproate (PDF/349.82 KB)
Adopted
First published: 22/09/2017
Last updated: 25/09/2017 -
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Summary of the EMA public hearing on valproate in pregnancy (PDF/289.38 KB)
First published: 04/10/2017
Last updated: 04/10/2017 -
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Public hearing on valproate - Written interventions (PDF/599.03 KB)
First published: 02/10/2017
Last updated: 02/10/2017
EMA/645752/2017 -
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Public hearing on Valproate - Summary of safety concerns and list of questions for the public hearing on Valproate (PDF/74.09 KB)
First published: 11/07/2017
Last updated: 11/07/2017
The PRAC held a public hearing on valproate and related substances on 26 September 2017.
To watch the video recording, click on the 'Multimedia' tab.
To view the documents for the public hearing, click on the 'Documents' tab.