Pharmacovigilance Risk Assessment Committee (PRAC): 25-29 September 2017

EventHumanPharmacovigilance

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Date

måndag, 25 september 2017, Hela dagen

Plats

European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Minutes of the PRAC meeting 25-29 September 2017

Adopted Reference Number: EMA/PRAC/782068/2017

English (EN) (1 MB - PDF)

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Agenda - PRAC draft agenda of meeting 25-29 September 2017

Draft Reference Number: EMA/PRAC/634126/2017

English (EN) (497.54 KB - PDF)

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Agenda - Public hearing: Valproate

Adopted

English (EN) (349.82 KB - PDF)

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Summary of the EMA public hearing on valproate in pregnancy

English (EN) (289.38 KB - PDF)

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Public hearing on valproate - Written interventions

Reference Number: EMA/645752/2017

English (EN) (599.03 KB - PDF)

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Public hearing on Valproate - Summary of safety concerns and list of questions for the public hearing on Valproate

English (EN) (74.09 KB - PDF)

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