52 results
Keyword Benefix Remove keyword
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Human medicine European public assessment report (EPAR): BeneFIX
Nonacog alfa, Hemophilia B
Date of authorisation: 27/08/1997, Revision: 42, Authorised, Last updated: 17/10/2022BeneFIX Blood Coagulation Disorders Hematologic … BeneFIX … summary for the public BeneFIX nonacog alfa This document … -
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News: Public Statement on Benefix (Nonacog alfa): Intensive Post-marketing Surveillance for all New patients + New Clinical Trials
Last updated: 04/10/2001Public Statement on Benefix (Nonacog alfa): Intensive … new patients treated with BeneFIX (nonacog alfa, human recombinant … Marketing Authorisation for BeneFIX is based, revealed deficiencies … -
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Orphan designation: Pegylated recombinant human factor IX (nonacog beta pegol) for: Treatment of haemophilia B
Date of designation: 15/05/2009, Expired, Last updated: 03/08/2017already available in the EU as Benefix for the treatment of haemophilia … human factor IX differs from Benefix in that it has been modified … already available in the EU as Benefix for the treatment of haemophilia … -
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Human medicine European public assessment report (EPAR): Idelvion
albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016,
, Revision: 11, Authorised, Last updated: 04/05/2023
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Human medicine European public assessment report (EPAR): Refixia
Nonacog beta pegol, Hemophilia B
Date of authorisation: 02/06/2017,
, Revision: 3, Authorised, Last updated: 16/12/2022
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Human medicine European public assessment report (EPAR): Rixubis
nonacog gamma, Hemophilia B
Date of authorisation: 19/12/2014, Revision: 11, Authorised, Last updated: 26/09/2022 -
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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
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Human medicine European public assessment report (EPAR): Hemgenix
Etranacogene dezaparvovec, Hemophilia B
Date of authorisation: 20/02/2023,, , 
, Revision: 1, Authorised, Last updated: 13/04/2023
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Withdrawn application: IXinity
date of withdrawal: 13/06/2013, Initial authorisation, Last updated: 18/09/2013 -
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Joint EMA / European Directorate for the Quality of Medicines and Healthcare workshop on characterisation of new clotting-factor concentrates with respect to potency assays used for labelling and testing of post-infusion samples
European Medicines Agency, London, UK, from 28/11/2013 to 29/11/2013, Last updated: 10/09/2013 -
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Press release: Committee for Proprietary Medicinal Products (CPMP) 30th plenary meeting
Last updated: 25/09/1997pertussis and hepatitis B, Benefix (nonacog alpha) for control … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 March 2013
European Medicines Agency, London, UK, from 04/03/2013 to 07/03/2013, Last updated: 02/06/2012 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 February 2017
European Medicines Agency, London, UK, from 20/02/2017 to 23/02/2017, Last updated: 06/01/2014 -
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Committee for Medicinal Products for Human Use (CHMP): 18-21 May 2015
European Medicines Agency, London, UK, from 18/05/2015 to 21/05/2015, Last updated: 03/01/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 March 2014
European Medicines Agency, London, UK, from 03/03/2014 to 06/03/2014, Last updated: 13/08/2013 -
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Committee for Medicinal Products for Human Use (CHMP): 23-26 January 2017
European Medicines Agency, London, UK, from 23/01/2017 to 26/01/2017, Last updated: 06/01/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 March 2017
European Medicines Agency, London, UK, from 06/03/2017 to 09/03/2017, Last updated: 06/03/2017 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 07/06/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 March 2018
European Medicines Agency, London, UK, from 05/03/2018 to 08/03/2018, Last updated: 05/03/2018 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 March 2021
European Medicines Agency, Amsterdam, the Netherlands, from 08/03/2021 to 11/03/2021, Last updated: 27/02/2018 -
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Sampling and testing
Last updated: 28/03/2019 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 June 2015
European Medicines Agency, London, UK, from 08/06/2015 to 11/06/2015, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 May 2015
European Medicines Agency, London, UK, from 04/05/2015 to 07/05/2015, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 March 2015
European Medicines Agency, London, UK, from 09/03/2015 to 12/03/2015, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 March 2016
European Medicines Agency, London, UK, from 14/03/2016 to 17/03/2016, Last updated: 13/03/2014