Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2018
EventHumanPharmacovigilance
Date
- Monday, 11 June 2018
Location
- 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 11-14 June 2018
AdoptedReference Number: EMA/PRAC/400242/2018
English (EN) (624.07 KB - PDF)
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Agenda - PRAC draft agenda of meeting 11-14 June 2018
DraftReference Number: EMA/PRAC/395628/2018
English (EN) (633.11 KB - PDF)
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Agenda and list of speakers - Public Hearing: quinolone and fluoroquinolone medicines
English (EN) (355.63 KB - PDF)
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Public hearing on quinolones and fluoroquinolones - Summary of safety concerns and list of questions
Reference Number: EMA/166405/2018
English (EN) (200.31 KB - PDF)
First published: Last updated:
Summary of the EMA public hearing on quinolone and fluoroquinolone antibiotics
English (EN) (273.78 KB - PDF)
First published: Last updated:
български (BG) (254.09 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
español (ES) (223.77 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
čeština (CS) (245.83 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
dansk (DA) (220.97 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
Deutsch (DE) (225.02 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
eesti keel (ET) (219.98 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
ελληνικά (EL) (260.1 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
français (FR) (225.33 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
hrvatski (HR) (239.57 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
italiano (IT) (222.54 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
latviešu valoda (LV) (252.56 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
lietuvių kalba (LT) (244.9 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
magyar (HU) (246.89 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
Malti (MT) (250.25 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
Nederlands (NL) (223.78 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
polski (PL) (249.58 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
português (PT) (224.7 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
română (RO) (248.09 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
slovenčina (SK) (244.56 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
slovenščina (SL) (241.23 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
Suomi (FI) (222.25 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
svenska (SV) (221.21 KB - PDF)
First published: 20/06/2018Last updated: 12/07/2018
Public hearing on quinolone and fluoroquinolone - Written interventions
Reference Number: EMA/225564/2018 Corr. *
English (EN) (825.63 KB - PDF)
First published: Last updated:
Multimedia
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.
Video recording of public hearing
The PRAC held a public hearing on quinolone and fluoroquinolone antibiotics on 13 June 2018.
To watch the video recording, click on the 'Multimedia' tab.