80 results
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Human medicine European public assessment report (EPAR): Vylaer Spiromax
Budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive; Asthma
Date of authorisation: 19/11/2014, Revision: 3, Withdrawn, Last updated: 26/01/2017 -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Pharma B.V.
clopidogrel (as hydrobromide), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 16/06/2011,
, Revision: 4, Withdrawn, Last updated: 03/02/2015
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Generics B.V.
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/10/2010,, Revision: 3, Withdrawn, Last updated: 12/05/2014
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Human medicine European public assessment report (EPAR): Biograstim
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,
, Revision: 8, Withdrawn, Last updated: 19/01/2017
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Human medicine European public assessment report (EPAR): Rivastigmine Teva
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 17/04/2009,, Revision: 4, Withdrawn, Last updated: 27/09/2012
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Human medicine European public assessment report (EPAR): Filgrastim ratiopharm
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 1, Withdrawn, Last updated: 20/07/2011
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Human medicine European public assessment report (EPAR): Tysabri
natalizumab, Multiple Sclerosis
Date of authorisation: 27/06/2006, Revision: 40, Authorised, Last updated: 13/09/2022 -
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National expert: Marleen Renard, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 43.05 KB | PDF
- Curriculum Vitae - 48.6 KB | PDF
Mehtsun W, Cananzi FCM, Sicoli F, Quagliuolo V, Chen J … -
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Orphan designation: Synthetic double-stranded oligomer specific to the SERPINA1 gene and containing a cholesterol-conjugated, acyclic nucleobase analogue for: Treatment of congenital alpha-1 antitrypsin deficiency
Date of designation: 11/01/2016, Withdrawn, Last updated: 17/05/2017 -
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Orphan designation: Nitric oxide for: Treatment of cystic fibrosis
Date of designation: 15/10/2014, Positive, -
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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: 17/05/2023 -
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Paediatric Committee (PDCO): 29 May – 1 June 2018
European Medicines Agency, London, UK, from 29/05/2018 to 01/06/2018, Last updated: 25/07/2018 -
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PRAC recommendations on safety signals (updated)
Last updated: 08/05/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 February 2018
European Medicines Agency, London, UK, from 05/02/2018 to 08/02/2018, Last updated: 13/03/2014 -
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Paediatric Committee (PDCO): 18-21 July 2017
European Medicines Agency, London, UK, from 18/07/2017 to 21/07/2017, Last updated: 03/07/2014 -
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Annual reports and work programmes (updated)
Last updated: 15/05/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 February 2018
European Medicines Agency, London, UK, from 19/02/2018 to 22/02/2018, Last updated: 06/04/2018 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 September 2014
European Medicines Agency, London, UK, from 08/09/2014 to 11/09/2014, Last updated: 13/08/2013 -
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Press release: Antimicrobial resistance - European Medicines Agency provides advice on use of colistin and tigecycline in animals
Last updated: 30/07/2013 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 November 2014
European Medicines Agency, London, UK, from 03/11/2014 to 06/11/2014, Last updated: 13/08/2013 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 1-4 December 2014
European Medicines Agency, London, UK, from 01/12/2014 to 04/12/2014, Last updated: 13/08/2013 -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,21-24 July 2008
CHMP, Last updated: 25/07/2008marketed in Lithuania by Sicor Biotech UAB (part of Teva … -
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Guidance documents
Last updated: 19/07/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 May 2018
European Medicines Agency, London, UK, from 14/05/2018 to 17/05/2018, Last updated: 14/05/2018