50 results
Keyword Edaravone Remove keyword
-
List item
Orphan designation: edaravone for: Treatment of amyotrophic lateral sclerosis
Date of designation: 19/06/2015, Positive, Last updated: 21/07/2023edaravone Overview On 19 June 2015 … Ltd, United Kingdom, for edaravone for the treatment of amyotrophic … information to show that edaravone might be of significant benefit … -
List item
Orphan designation: edaravone for: Treatment of amyotrophic lateral sclerosis
Date of designation: 16/12/2014, Positive, Last updated: 27/03/2023edaravone … opinion on orphan designation Edaravone for the treatment of amyotrophic … opinion on orphan designation Edaravone for the treatment of amyotrophic … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): edaravone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002785-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 10/05/2021, Last updated: 14/02/2022, Compliance check: XKey facts edaravone NeurologyP/0203/2021EMEA-002785-PIP01-20 … granting of a waiver for edaravone (EMEA-002785-PIP01-20) PDF … granting of a waiver for edaravone (EMEA-002785-PIP01-20) in … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): edaravone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002897-PIP01-20, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Solution for infusion, Oral suspension
Decision date: 17/03/2021, Last updated: 09/11/2021, Compliance check: XKey facts edaravone NeurologyP/0095/2021EMEA-002897-PIP01-20 … product specific waiver for edaravone (EMEA-002897-PIP01-20) PDF … product specific waiver for edaravone (EMEA-002897-PIP01-20) in … -
List item
Withdrawn application: Radicava
date of withdrawal: 24/05/2019, Initial authorisation, Last updated: 14/08/2019Radicava Radicava edaravone … -
List item
National expert: Markus Weber, European Medicines Agency (updated)
- Declaration of interests - 40.87 KB | PDF
- Curriculum Vitae - 55.89 KB | PDF
Tanabe Individual product related Edaravone ALS 1.3 Strategic advisory … -
List item
National expert: Patrick Weydt, European Medicines Agency (updated)
- Declaration of interests - 43.32 KB | PDF
- Curriculum Vitae - 30.19 KB | PDF
disease Current 01-11- 2021 22-03- 2023 Mitsubishi Tanabe Edaravone (oral) Amyotrophic Lateral … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-29 May 2019
CHMP, Last updated: 29/05/2019edaravone) have been withdrawn. Ambrisentan … -
List item
National expert: Massimiliano Filosto, European Medicines Agency (updated)
- Declaration of interests - 44.71 KB | PDF
- Curriculum Vitae - 35.96 KB | PDF
intravenous administration of Edaravone in Amyotrophic Lateral Sclerosis … -
List item
Human medicine European public assessment report (EPAR): Pradaxa (updated)
Dabigatran etexilate mesilate, Arthroplasty, Replacement; Venous Thromboembolism
Date of authorisation: 17/03/2008, Revision: 40, Authorised, Last updated: 24/11/2023 -
List item
COMP: Agendas, minutes and meeting reports (updated)
Last updated: 07/11/2023 -
List item
PDCO: Agendas, minutes and reports (updated)
Last updated: 28/11/2023 -
List item
Paediatric Committee (PDCO): 23-26 March 2021
Virtual meeting, from 23/03/2021 to 26/03/2021, Last updated: 12/05/2021EMEA-002775-PIP01-20 ............ 8 2.1.5. Edaravone - Orphan - EMEA-002785-PIP01-20 … -
List item
Paediatric Committee (PDCO): 26-29 January 2021
Virtual meeting, from 26/01/2021 to 29/01/2021, Last updated: 11/03/2021 -
List item
Paediatric Committee (PDCO): 23-26 February 2021
Virtual meeting, from 23/02/2021 to 26/02/2021, Last updated: 23/02/2021 -
List item
Paediatric Committee (PDCO): 8-11 December 2020
Virtual meeting, from 08/12/2020 to 11/12/2020, Last updated: 01/03/2021 -
List item
Committee for Orphan Medicinal Products (COMP): 12-13 May 2015
European Medicines Agency, London, UK, from 12/05/2015 to 13/05/2015, Last updated: 26/09/2013 -
List item
Committee for Orphan Medicinal Products (COMP): 11-13 November 2014
European Medicines Agency, London, UK, from 11/11/2014 to 13/11/2014, Last updated: 08/05/2012 -
List item
Committee for Orphan Medicinal Products (COMP): 17-19 April 2018
European Medicines Agency, London, UK, from 17/04/2018 to 19/04/2018, Last updated: 16/04/2018 -
List item
Paediatric Committee (PDCO): 15-17 July 2015
European Medicines Agency, London, UK, from 15/07/2015 to 17/07/2015, Last updated: 17/08/20157 6.1.1. Edaravone - EMEA-24-2015 … -
List item
Committee for Orphan Medicinal Products (COMP): 13-15 March 2018
European Medicines Agency, London, UK, from 13/03/2018 to 15/03/2018, Last updated: 19/06/2014 -
List item
Committee for Orphan Medicinal Products (COMP): 19-21 April 2016
European Medicines Agency, London, UK, from 19/04/2016 to 21/04/2016, Last updated: 17/06/2014 -
List item
Committee for Orphan Medicinal Products (COMP): 21-23 March 2016
European Medicines Agency, London, UK, from 21/03/2016 to 23/03/2016, Last updated: 17/06/2016 -
List item
Committee for Orphan Medicinal Products (COMP): 3-5 October 2017
European Medicines Agency, London, UK, from 03/10/2017 to 05/10/2017, Last updated: 19/06/2014 -
List item
Committee for Orphan Medicinal Products (COMP): 14-16 February 2017
European Medicines Agency, London, UK, from 14/02/2017 to 16/02/2017, Last updated: 19/06/2014