28 results
Keyword Remifentanil Remove keyword
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National expert: Joerg Zinserling, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 25.26 KB | PDF
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National expert: Pieter Colin, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 80.41 KB | PDF
- Curriculum Vitae - 30.13 KB | PDF
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National expert: Katrien Oude Rengerink, Medicines Evaluation Board (updated)
- Declaration of interests - 81.79 KB | PDF
- Curriculum Vitae - 36.3 KB | PDF
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Human medicine European public assessment report (EPAR): Byfavo (updated)
remimazolam, Conscious Sedation
Date of authorisation: 26/03/2021,
, Revision: 3, Authorised, Last updated: 06/01/2023
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Human medicine European public assessment report (EPAR): Moventig
naloxegol oxalate, Constipation; Opioid-Related Disorders
Date of authorisation: 07/12/2014, Revision: 15, Authorised, Last updated: 09/12/2022 -
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Human medicine European public assessment report (EPAR): Dexdor
dexmedetomidine hydrochloride, Conscious Sedation
Date of authorisation: 15/09/2011, Revision: 15, Authorised, Last updated: 14/07/2022 -
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Human medicine European public assessment report (EPAR): Bridion
sugammadex, Neuromuscular Blockade
Date of authorisation: 25/07/2008, Revision: 21, Authorised, Last updated: 22/12/2022 -
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Human medicine European public assessment report (EPAR): Exparel liposomal
bupivacaine, Acute Pain
Date of authorisation: 16/11/2020, Revision: 1, Authorised, Last updated: 14/11/2022 -
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Human medicine European public assessment report (EPAR): Vidaza
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,
, Revision: 25, Authorised, Last updated: 14/06/2022
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National expert: Caridad Pontes, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 80.92 KB | PDF
- Curriculum Vitae - 49.74 KB | PDF
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National expert: Steffen Rex, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 82.35 KB | PDF
- Curriculum Vitae - 44.83 KB | PDF
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National expert: Theodoros Sergentanis, National Organization for Medicines (updated)
- Declaration of interests - 79.93 KB | PDF
- Curriculum Vitae - 71.79 KB | PDF
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Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 January 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/01/2022 to 13/01/2022, Last updated: 07/10/2022 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 18/01/2023 -
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Workshop on Neonates
London, 11/10/2006, Last updated: 11/10/2006 -
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Guidance documents
Last updated: 19/07/2022 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 13 January 2022
PRAC, Last updated: 14/01/2022 -
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News: EMA's medical literature monitoring enters into full operation
Last updated: 01/09/2015 -
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News: Safety monitoring of medicines: EMA to screen medical literature for 400 active substance groups
Last updated: 12/05/2015 -
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Clinical Trials Regulation: progress on implementation
Last updated: 20/05/2022 -
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Periodic safety update reports (PSURs)
Last updated: 27/07/2022 -
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Second annual scientific workshop at EMA: Applying regulatory science to neonates
European Medicines Agency, London, UK, from 12/09/2016 to 13/09/2016, Last updated: 19/10/2016 -
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News: Feedback requested on the draft list of EU reference dates for periodic safety update reports in preparation for introduction of the new pharmacovigilance legislation
Last updated: 04/04/2012 -
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Needs for paediatric medicines
Last updated: 11/05/2016