45 results
Keyword Alprolix Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Alprolix, eftrenonacog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000914-PIP01-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 18/03/2020, Last updated: 03/08/2020, Compliance check: V, 24/07/2020Invented name Alprolix Active substance eftrenonacog … Alprolix Alprolix eftrenonacog alfa eftrenonacog … -
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Human medicine European public assessment report (EPAR): Alprolix
eftrenonacog alfa, Hemophilia B
Date of authorisation: 12/05/2016,
, Revision: 8, Authorised, Last updated: 04/11/2021
Alprolix Blood Coagulation Disorders Hematologic … assessment report (EPAR) for Alprolix. It explains how the Agency … practical advice on how to use Alprolix. For practical information … -
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Orphan designation: Recombinant fusion protein consisting of human coagulation factor IX attached to the Fc domain of human IgG1 for: Treatment of haemophilia B (congenital factor IX deficiency)
Date of designation: 08/06/2007, Positive, Last updated: 30/05/2016been authorised in the EU as Alprolix since 12 May 2016. Expand … Alprolix Alprolix eftrenonacog alfa Recombinant … designation EU/3/07/453 for Alprolix (eftrenonacog alfa 1 ) as … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 2016
CHMP, Last updated: 26/02/2016Alprolix … -
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Opinion/decision on a Paediatric investigation plan (PIP): Vitekta, elvitegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000968-PIP02-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 07/10/2016, Last updated: 24/11/2016, Compliance check: Xplan for eftrenonacog alfa (ALPROLIX), (EMEA-000914-PIP01-10-M03 … -
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National expert: Ana Boban, European Medicines Agency (updated)
- Declaration of interests - 82.99 KB | PDF
- Curriculum Vitae - 17.84 KB | PDF
hemoglobinuria 05/2022-(current) Sobi Alprolix Hemophilia B 05/2022-(current … -
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Human medicine European public assessment report (EPAR): Refixia
Nonacog beta pegol, Hemophilia B
Date of authorisation: 02/06/2017,
, Revision: 2, Authorised, Last updated: 07/03/2022
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PRAC: Agendas, minutes and highlights
Last updated: 04/07/2022 -
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COMP: Agendas, minutes and meeting reports (updated)
Last updated: 21/07/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 September-1 October 2020
Virtual meeting, from 28/09/2020 to 01/10/2020, Last updated: 29/09/2020 -
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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 -
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Download medicine data
Last updated: 02/12/2021 -
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Committee for Orphan Medicinal Products (COMP): 10-11 April 2017
European Medicines Agency, London, UK, from 10/04/2017 to 11/04/2017, Last updated: 19/06/2014 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 18/08/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 23-26 November 2020
Virtual meeting, from 23/11/2020 to 26/11/2020, Last updated: 27/11/2020 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 April 2018
European Medicines Agency, London, UK, from 09/04/2018 to 12/04/2018, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 April 2017
European Medicines Agency, London, UK, from 03/04/2017 to 06/04/2017, Last updated: 13/03/2014 -
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Workshop on haemophilia registries
European Medicines Agency, London, UK, from 01/07/2015 to 02/07/2015, Last updated: 03/08/2015 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 June 2021
European Medicines Agency, Amsterdam, the Netherlands, from 21/06/2021 to 24/06/2021, Last updated: 07/12/2021 -
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Support for industry on clinical data publication
Last updated: 16/09/2020 -
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Committee for Medicinal Products for Human Use (CHMP): 22-25 February 2016
European Medicines Agency, London, UK, from 22/02/2016 to 25/02/2016, Last updated: 06/01/201410 3.1.1. Alprolix - eftrenonacog alfa - Orphan … -
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Update on the implementation of policy on publication of clinical data (Policy 0070) – Industry associations webinar
European Medicines Agency, London, UK, 29/06/2017, Last updated: 05/07/2017Rasagiline Mylan 02 June 2017 7 Alprolix 02 June 2017 16 Bortezomib … -
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News: EMA's proactive publication of clinical data a success
Last updated: 16/07/2018 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 25-29 September 2017
European Medicines Agency, London, UK, from 25/09/2017 to 29/09/2017, Last updated: 06/09/2017 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 31 August-3 September 2020
Virtual meeting, from 31/08/2020 to 03/09/2020, Last updated: 27/02/2018