77 results
Keyword Kovaltry Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Iblias, octocog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001064-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 16/03/2018, Last updated: 10/03/2023, Compliance check: V, 23/07/2021Key facts Iblias Kovaltry octocog alfa Haematology-HemostaseologyP/0060/2018EMEA-001064-PIP01-10-M03 … for octocog alfa (Iblias, Kovaltry) (EMEA-001064-PIP01-10-M03 … EMA/102305/2018 Generic Iblias: EPAR Kovaltry: EPAR Factor VIII: Article … -
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Human medicine European public assessment report (EPAR): Kovaltry
octocog alfa, Hemophilia A
Date of authorisation: 18/02/2016, Revision: 11, Authorised, Last updated: 26/07/2022Kovaltry Blood Coagulation Disorders … Kovaltry … summary for the public Kovaltry octocog alfa This is a … -
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Referral: Factor VIII
associated names: Iblias, Elocta, Kovaltry, Nuwiq, Obizur, NovoEight, Voncento, ReFacto AF, Kogenate Bayer, Helixate NexGen, Advate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/09/2017, EC decision date: 10/10/2017, Last updated: 05/12/2017Iblias Elocta Kovaltry Nuwiq Obizur NovoEight Voncento ReFacto … NexGen Advate Iblias Elocta Kovaltry Nuwiq Obizur NovoEight Voncento ReFacto … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 December 2015
CHMP, Last updated: 18/12/2015Kovaltry … -
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Human medicine European public assessment report (EPAR): Kogenate Bayer
octocog alfa, Hemophilia A
Date of authorisation: 04/08/2000, Revision: 30, Withdrawn, Last updated: 02/03/2023 -
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Human medicine European public assessment report (EPAR): Elocta
efmoroctocog alfa, Hemophilia A
Date of authorisation: 18/11/2015, Revision: 12, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Nuwiq
simoctocog alfa, Hemophilia A
Date of authorisation: 22/07/2014, Revision: 13, Authorised, Last updated: 21/03/2023EMEA/H/C/0275/A31/0185 Kovaltry EMEA/H/C/3825/A31/0004 NovoEight … -
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Press release: Factor VIII medicines: no clear and consistent evidence of difference in risk of inhibitor development between classes
CHMP, Last updated: 15/09/2017EPAR Kogenate Bayer: EPAR Kovaltry: EPAR NovoEight: EPAR Nuwiq … -
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Human medicine European public assessment report (EPAR): Obizur
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,
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, Revision: 10, Authorised, Last updated: 26/10/2022
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Human medicine European public assessment report (EPAR): ReFacto AF
moroctocog alfa, Hemophilia A
Date of authorisation: 13/04/1999, Revision: 40, Authorised, Last updated: 08/11/2022 -
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Human medicine European public assessment report (EPAR): Advate
octocog alfa, Hemophilia A
Date of authorisation: 02/03/2004, Revision: 31, Authorised, Last updated: 15/12/2022 -
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Human medicine European public assessment report (EPAR): Helixate NexGen
octocog alfa, Hemophilia A
Date of authorisation: 04/08/2000, Revision: 31, Withdrawn, Last updated: 02/06/2020 -
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Human medicine European public assessment report (EPAR): Roctavian
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,, 
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, Revision: 1, Authorised, Last updated: 09/11/2022
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Human medicine European public assessment report (EPAR): Voncento
Human coagulation factor VIII, human von willebrand factor, Hemophilia A; von Willebrand Diseases
Date of authorisation: 12/08/2013, Revision: 15, Authorised, Last updated: 13/05/2022 -
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Human medicine European public assessment report (EPAR): NovoEight
turoctocog alfa, Hemophilia A
Date of authorisation: 13/11/2013, Revision: 13, Authorised, Last updated: 19/05/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 11/04/2023 to 14/04/2023, Last updated: 11/04/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 07/06/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 February 2023
European Medicines Agency, Amsterdam, the Netherlands, from 20/02/2023 to 23/02/2023, Last updated: 24/04/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 February 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/02/2022 to 10/02/2022, Last updated: 07/11/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 November-2 December 2021
European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2021 to 02/12/2021, Last updated: 04/10/2022 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 06/06/2023 -
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Substance and product data management services
Last updated: 09/02/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 23-26 January 2023
European Medicines Agency, Amsterdam, the Netherlands, from 23/01/2023 to 26/01/2023, Last updated: 14/04/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 August - 1 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 29/08/2022 to 01/09/2022, Last updated: 02/09/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2022
European Medicines Agency, Amsterdam, the Netherlands, from 19/04/2022 to 22/04/2022, Last updated: 12/08/2022