85 results
Keyword Aranesp Remove keyword
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Withdrawn application: Aranesp
darbepoetin alfa, date of withdrawal: 21/02/2018, Post-authorisation, Last updated: 24/04/2018Aranesp: Withdrawn application … marketing authorisation for Aranesp (darbepoetin alfa) On … authorisation. What is Aranesp? Aranesp is a medicine already used … -
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Opinion/decision on a Paediatric investigation plan (PIP): Aranesp, darbepoetin alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000329-PIP02-09-M05, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 14/06/2016, Last updated: 26/08/2016, Compliance check: X, 24/03/2017Invented name Aranesp Active substance darbepoetin … plan for darbepoetin alfa (Aranesp), (EMEA-000329-PIP02-09-M05 … plan for darbepoetin alfa (Aranesp), (EMEA-000329-PIP02-09-M05 … -
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Human medicine European public assessment report (EPAR): Aranesp
darbepoetin alfa, Anemia; Cancer; Kidney Failure, Chronic
Date of authorisation: 08/06/2001, Revision: 45, Authorised, Last updated: 11/11/2022Aranesp Hematologic Diseases Hemic … darbepoetin alfa Overview Aranesp is a medicine used to treat … originating in the bone marrow). Aranesp contains the The substance … -
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National expert: Filip Van Aelst, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 26.49 KB | PDF
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News: Public Statement: European Medicines Agency starts review of the safety of epoetins
Last updated: 28/04/2007Union/European Economic Area are Aranesp/Nespo, Dynepo and NeoRecormon. Eprex … Union/European Economic Area are Aranesp/Nespo, Dynepo and NeoRecormon … -
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National expert: Jolanta Malyszko, European Medicines Agency (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 23 KB | PDF
Agency 1. International Aranesp(R) Advisory Board Meeting"Anemia … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018
CHMP, Last updated: 23/03/2018Aranesp … -
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News: Public Statement: Epoetins and the risk of tumour growth progression and thromboembolic events in cancer patients and cardiovascular risks in patients with chronic kidney disease
CHMP, Last updated: 23/10/2007centrally authorised epoetins (Aranesp/Nespo, Dynepo, Mircera, NeoRecormon … -
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National expert: Guy Berchem, Ministry Of Health (updated)
- Declaration of interests - 85.35 KB | PDF
- Curriculum Vitae - 41.53 KB | PDF
cancer 01/2010-07/2015 Amgen Aranesp Lung cancer 01/2010-03/2012 … -
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Press release: EMEA recommends a new warning for epoetins for their use in cancer patients
CHMP, Last updated: 26/06/2008and Erypo (epoetin alfa), Aranesp and Nespo (darbepoetin alfa … Erypo (epoetin alfa), Aranesp and Nespo (darbepoetin alfa … -
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Human medicine European public assessment report (EPAR): Mircera (updated)
Methoxy polyethylene glycol-epoetin beta, Anemia; Kidney Failure, Chronic
Date of authorisation: 20/07/2007, Revision: 28, Authorised, Last updated: 20/03/2023 -
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Human medicine European public assessment report (EPAR): Evrenzo
Roxadustat, Anemia; Kidney Failure, Chronic
Date of authorisation: 18/08/2021,
, Revision: 2, Authorised, Last updated: 18/10/2022
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Human medicine European public assessment report (EPAR): Nespo
darbepoetin alfa, Kidney Failure, Chronic; Anemia; Cancer
Date of authorisation: 08/06/2001, Revision: 19, Withdrawn, Last updated: 28/01/2009 -
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Withdrawn application: Omontys
date of withdrawal: 28/06/2013, Initial authorisation, Last updated: 28/06/2013 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 May 2022
European Medicines Agency, Amsterdam, the Netherlands, from 02/05/2022 to 05/05/2022, Last updated: 06/02/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 February 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 20/02/2023 to 23/02/2023, Last updated: 20/02/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/03/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 26/09/2022 to 29/09/2022, Last updated: 04/07/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 7-10 November 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/11/2022 to 10/11/2022, Last updated: 10/01/2023 -
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PRAC recommendations on safety signals (updated)
Last updated: 06/03/2023 -
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CHMP: Agendas, minutes and highlights
Last updated: 08/02/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 17-20 May 2021
European Medicines Agency, Amsterdam, the Netherlands, from 17/05/2021 to 20/05/2021, Last updated: 07/12/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2022 to 24/03/2022, Last updated: 12/08/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 24-27 January 2022
European Medicines Agency, Amsterdam, the Netherlands, from 24/01/2022 to 27/01/2022, Last updated: 16/03/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2021
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2021 to 10/06/2021, Last updated: 07/06/2021