111 results
Keyword Advate - Polvere Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Advate, octocog alfa
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: Octocog alfa, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 04/05/2010, Last updated: 28/07/2010, Compliance check: XInvented name Advate Active substance octocog … waiver for octocog alfa (Advate) (EMEA-000358-PIP02-09) in … waiver for octocog alfa (Advate) (EMEA-000358-PIP02-09) in … -
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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: 15/12/2022Advate Blood Coagulation Disorders … assessment report (EPAR) for Advate. It explains how the Agency … practical advice on how to use Advate. For practical information … -
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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: 05/12/2017AF Kogenate Bayer Helixate NexGen Advate Iblias Elocta Kovaltry Nuwiq Obizur NovoEight Voncento ReFacto … AF Kogenate Bayer Helixate NexGen Advate octocog alfa efmoroctocog … -
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News: EMEA Public Statement on review of recombinant Factor VIII (FVIII) products (Advate, Kogenate Bayer/Helixate NexGen, Kogenate/Helixate, Recombinate, ReFacto) and inhibitor development
Last updated: 18/10/2005Factor VIII (FVIII) products (Advate, Kogenate Bayer/Helixate … Factor VIII (FVIII) products (Advate, Kogenate Bayer/Helixate … and inhibitor development *Advate, Kogenate Bayer/Helixate … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 May 2016
PRAC, Last updated: 13/05/2016Advate: EPAR Helixate NexGen: EPAR … VIII: Article 31 referrals Advate: Paediatric investigation … medicines octocog alfa (Advate, Helixate Nexgen / Kogenate … -
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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: 15/09/2017Advate: EPAR Elocta: EPAR Helixate … VIII: Article 31 referrals Advate: Paediatric investigation … -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 15-18 November 2004
Last updated: 18/11/2004Advate … in the European Union: Advate (octocog alfa), Baxter AG … factor VIII deficiency). Advate was first authorised in … -
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News: EMEA completes the review of recombinant factor VIII products and inhibitor development
Last updated: 31/07/2007and inhibitor development *Advate, Kogenate Bayer/Helixate … Union/European Economic Area are Advate, Kogenate Bayer/Helixate … -
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Human medicine European public assessment report (EPAR): Adynovi (updated)
rurioctocog alfa pegol, Hemophilia A
Date of authorisation: 08/01/2018,
, Revision: 9, Authorised, Last updated: 02/06/2023
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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): Veyvondi
vonicog alfa, von Willebrand Diseases
Date of authorisation: 31/08/2018,, Revision: 6, Authorised, Last updated: 06/03/2023
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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): Nuwiq
simoctocog alfa, Hemophilia A
Date of authorisation: 22/07/2014, Revision: 13, Authorised, Last updated: 21/03/2023number(s): EMEA/H/A-31/1448 Advate EMEA/H/C/0520/A31/0078 Elocta … -
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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): Afstyla
lonoctocog alfa, Hemophilia A
Date of authorisation: 04/01/2017, Revision: 10, Authorised, Last updated: 25/07/2022 -
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Human medicine European public assessment report (EPAR): Obizur
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,, 
, Revision: 10, Authorised, Last updated: 26/10/2022
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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: 26/07/2022 -
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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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Human medicine European public assessment report (EPAR): Vihuma
simoctocog alfa, Hemophilia A
Date of authorisation: 13/02/2017,, Revision: 8, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Inrebic
fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders; Primary Myelofibrosis
Date of authorisation: 08/02/2021,, 
, Revision: 4, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Roctavian
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,, , 
, Revision: 1, Authorised, Last updated: 09/11/2022
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Human medicine European public assessment report (EPAR): Jakavi
ruxolitinib (as phosphate), Myeloproliferative Disorders; Polycythemia Vera; Graft vs Host Disease
Date of authorisation: 23/08/2012, Revision: 27, Authorised, Last updated: 17/01/2023 -
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National expert: Francesco Onida, Italian Medicines Agency (updated)
- Declaration of interests - 42.89 KB | PDF
- Curriculum Vitae - 66.85 KB | PDF
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National expert: Francesco Rodeghiero, European Medicines Agency (updated)
- Declaration of interests - 43.15 KB | PDF
- Curriculum Vitae - 121.63 KB | PDF