45 results
Keyword Aldurazyme Remove keyword
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Human medicine European public assessment report (EPAR): Aldurazyme
laronidase, Mucopolysaccharidosis I
Date of authorisation: 09/06/2003, Revision: 22, Authorised, Last updated: 24/11/2021Aldurazyme Mucopolysaccharidoses Carbohydrate … Aldurazyme … Aldurazyme, INN-laronidase 30 … -
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Orphan designation: laronidase for: Treatment of mucopolysaccharidosis type I
Date of designation: 15/02/2001, Expired, Last updated: 08/07/2013been authorised in the EU as Aldurazyme since 10 June 2003. For a … Update: laronidase (Aldurazyme) has been authorised in the … disease. More information on Aldurazyme can be found in the European … -
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Orphan designation: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene for: Treatment of mucopolysaccharidosis type I
Date of designation: 17/01/2018, Positive, Last updated: 30/07/2019designation, the medicine Aldurazyme (laronidase) was authorised … designation, the medicine Aldurazyme (laronidase) was authorised … -
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Orphan designation: Recombinant adeno-associated viral vector serotype 9 containing human iduronidase gene for: Treatment of mucopolysaccharidosis type I
Date of designation: 27/06/2018, Positive, Last updated: 22/08/2018designation, the medicine Aldurazyme (laronidase) was authorised … designation, the medicine Aldurazyme (laronidase) was authorised … -
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Orphan designation: Ataluren for: Treatment of mucopolysaccharidosis type I
Date of designation: 19/11/2014, Withdrawn, Last updated: 22/02/2018designation, the medicine Aldurazyme (laronidase) was authorised … designation, the medicine Aldurazyme (laronidase) was authorised … -
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Orphan designation: pentosan polysulfate sodium for: Treatment of mucopolysaccharidosis type I
Date of designation: 19/11/2014, Positive, Last updated: 15/12/2022designation, the medicine Aldurazyme (laronidase) was authorised … designation, the medicine Aldurazyme (laronidase) was authorised … -
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Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA for: Treatment of mucopolysaccharidosis type I
Date of designation: 26/10/2018, Positive, Last updated: 14/07/2022designation, the medicine Aldurazyme (laronidase) was authorised … -
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Orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate for: Treatment of mucopolysaccharidosis type I
Date of designation: 22/09/2016, Positive, Last updated: 24/05/2022designation, the medicine Aldurazyme (laronidase) was authorised … designation, the medicine Aldurazyme (laronidase) was authorised … -
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Orphan designation: Recombinant human insulin receptor monoclonal antibody-fused-α-L-iduronidase for: Treatment of mucopolysaccharidosis type I
Date of designation: 15/10/2014, Withdrawn, Last updated: 18/02/2022designation, the medicine Aldurazyme (laronidase) was authorised … designation, the medicine Aldurazyme (laronidase) was authorised … -
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Human medicine European public assessment report (EPAR): Naglazyme
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006, Revision: 19, Authorised, Last updated: 11/07/2022 -
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Human medicine European public assessment report (EPAR): Vimizim
recombinant human n-acetylgalactosamine-6-sulfatase, Mucopolysaccharidosis IV
Date of authorisation: 27/04/2014,
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, Revision: 12, Authorised, Last updated: 16/06/2021
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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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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: 20/02/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 24-27 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 24/10/2022 to 27/10/2022, Last updated: 04/07/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2022 to 10/06/2022, Last updated: 07/06/2022 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/03/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 9-12 November 2020
Virtual meeting, from 09/11/2020 to 12/11/2020, Last updated: 07/01/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 14-17 September 2020
Virtual meeting, from 14/09/2020 to 17/09/2020, Last updated: 10/03/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 September 2015
European Medicines Agency, London, UK, from 21/09/2015 to 24/09/2015, Last updated: 03/01/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 December 2013
European Medicines Agency, London, UK, from 02/12/2013 to 05/12/2013, Last updated: 02/07/2012 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 1-4 December 2014
European Medicines Agency, London, UK, from 01/12/2014 to 04/12/2014, Last updated: 13/08/2013 -
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Press release: European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 18 to 20 February 2003
Last updated: 24/02/2003applications at this meeting for Aldurazyme (laronidase), from Genzyme … review time of 209 days. Aldurazyme was designated an orphan … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 September 2013
European Medicines Agency, London, UK, from 02/09/2013 to 05/09/2013, Last updated: 02/07/2012 -
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Download medicine data
Last updated: 02/12/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 November 2015
European Medicines Agency, London, UK, from 03/11/2015 to 06/11/2015, Last updated: 13/03/2014