Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2018
Date:
11/06/2018 to 14/06/2018
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 11-14 June 2018 (PDF/624.07 KB)
Adopted
First published: 10/08/2018
Last updated: 10/08/2018
EMA/PRAC/400242/2018 -
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Agenda - PRAC draft agenda of meeting 11-14 June 2018 (PDF/633.11 KB)
Draft
First published: 11/06/2018
Last updated: 11/06/2018
EMA/PRAC/395628/2018 -
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Agenda and list of speakers - Public Hearing: quinolone and fluoroquinolone medicines (PDF/355.63 KB)
First published: 07/06/2018
Last updated: 11/06/2018 -
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Public hearing on quinolones and fluoroquinolones - Summary of safety concerns and list of questions (PDF/200.31 KB)
First published: 09/04/2018
Last updated: 09/04/2018
EMA/166405/2018 -
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Summary of the EMA public hearing on quinolone and fluoroquinolone antibiotics (PDF/273.78 KB)
First published: 20/06/2018
Last updated: 12/07/2018 -
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Public hearing on quinolone and fluoroquinolone - Written interventions (PDF/825.63 KB)
First published: 20/06/2018
Last updated: 25/06/2018
EMA/225564/2018 Corr. *
The PRAC held a public hearing on quinolone and fluoroquinolone antibiotics on 13 June 2018.
The hearing was broadcast live on 13 June from 13:00 - 18:00 (UK time).
The video recording is available.