648 results
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Orphan designation: recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1 for: Treatment of adenosine triphosphate binding cassette transporter protein subfamily C member 6 deficiency
Date of designation: 19/07/2021, Positive, Last updated: 16/11/2021protein subfamily C member 6 (ABCC6) deficiency in the European … expected to work Patients with ABCC6 deficiency have mutations … mutations (changes) in the ABCC6 gene, which controls production … -
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Human medicine European public assessment report (EPAR): Iscover
clopidogrel, Stroke; Peripheral Vascular Diseases; Atrial Fibrillation; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 14/07/1998, Revision: 49, Authorised, Last updated: 16/02/2023moderate to high-risk TIA (ABCD2 score ≥4) or minor IS … -
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Human medicine European public assessment report (EPAR): Plavix
clopidogrel hydrogen sulfate, Stroke; Peripheral Vascular Diseases; Atrial Fibrillation; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 15/07/1998, Revision: 48, Authorised, Last updated: 15/02/2023moderate to high-risk TIA (ABCD2 score ≥4) or minor IS … -
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Human medicine European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma)
clopidogrel besilate, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 16/10/2009,
, Revision: 26, Authorised, Last updated: 03/08/2022
moderate to high-risk TIA (ABCD2 score ≥4) or minor IS … -
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Human medicine European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Mylan)
clopidogrel hydrochloride, Peripheral Vascular Diseases; Stroke; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 21/09/2009,, Revision: 20, Authorised, Last updated: 01/07/2022
moderate to high-risk TIA (ABCD2 score ≥4) or minor IS … -
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National expert: Michela Palmisano, Italian Medicines Agency (updated)
- Declaration of interests - 42.96 KB | PDF
- Curriculum Vitae - 32.6 KB | PDF
Cellulare e del Differenziamento (ABCD), Ravenna, September 2011 … September 2010 (1 poster) ▪ ABCD PhD National Meeting, Gubbio … June 2010 (1 poster) ▪ ABCD, Stem cells, Development and … -
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National expert: Martina Cesani, Italian Medicines Agency (updated)
- Declaration of interests - 42.69 KB | PDF
- Curriculum Vitae - 32.61 KB | PDF
5’_half sequence of human ABCA4 gene and the 3’_half sequence … 3’_half sequence of human ABCA4 gene for the treatment of … coding sequences of human ABCA4 fused to inteins; ODD EU/3/19/2208 … -
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Orphan designation: Temsirolimus for: Treatment of adrenoleukodystrophy
Date of designation: 30/05/2016, Positive, Last updated: 11/11/2022abnormalities in a gene called ABCD1 which is responsible for … abnormalities in a gene called ABCD1 which is responsible for … -
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Orphan designation: dimethyl fumarate for: Treatment of adrenoleukodystrophy
Date of designation: 09/01/2020, Positive, Last updated: 11/11/2022ABCD1 … -
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News: First gene therapy to treat children with rare inherited neurological disease
CHMP, Last updated: 21/05/2021abnormalities in a gene called ABCD1 which is responsible for … functional copy of the gene ABCD1 for the ALDP protein, so … 18 years of age, with an ABCD1 genetic mutation, and for … -
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National expert: Christopher Jarvis, European Medicines Agency (updated)
- Declaration of interests - 39.3 KB | PDF
- Curriculum Vitae - 27.24 KB | PDF
Nucleoside Analogues with Aciclovir. 4th Annual Skin Network Meeting … -
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Orphan designation: 5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride for: Treatment of adrenoleukodystrophy
Date of designation: 18/11/2016, Positive, Last updated: 13/12/2016abnormalities in a gene called ABCD1 which is responsible for … abnormalities in a gene called ABCD1 which is responsible for … -
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Orphan designation: pioglitazone for: Treatment of adrenoleukodystrophy
Date of designation: 19/02/2014, Positive, Last updated: 02/04/2014abnormalities in a gene called ABCD1 which is responsible for … abnormalities in a gene called ABCD1 which is responsible for … -
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Orphan designation: Human embryonic stem-cell-derived retinal pigment epithelial cells for: Treatment of Stargardt's disease
Date of designation: 21/06/2011, Positive, Last updated: 12/07/2011disease lack a protein called ABCR, which controls the movement … -
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Orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes for: Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity
Date of designation: 09/08/2012, Withdrawn, Last updated: 21/02/2019several antiviral medicines (aciclovir, ganciclovir, valaciclovir … -
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National expert: Maria Del Val Bermejo Sanz, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 41.53 KB | PDF
- Curriculum Vitae - 37.65 KB | PDF
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National expert: Balázs Sarkadi, National Institute of Pharmacy and Nutrition (updated)
- Declaration of interests - 43.23 KB | PDF
- Curriculum Vitae - 124.58 KB | PDF
by overexpression of the ABCG2 multidrug transporter in … parallel measurements of the ABCG2, ABCB1 and ABCC1 multidrug transporter functions … http://www.google.com/patents/US8129197 „ABC transporter assay” Balazs … -
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National expert: Martin Bauer, Austrian Agency for Health and Food Safety (updated)
- Declaration of interests - 43.29 KB | PDF
- Curriculum Vitae - 225.8 KB | PDF
microdialysis, PET/MR imaging of ABC transporters, Phase I_II … microdialysis, PET/MR imaging of ABC transporters • Country … PI of academic studies on ABC and OATP transporters at … -
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National expert: Patrick Weydt, European Medicines Agency (updated)
- Declaration of interests - 42.64 KB | PDF
- Curriculum Vitae - 30.19 KB | PDF
trial on Rituximab in ALS (ABCD study). The trial is expected … -
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National expert: Illiana Meurs, Medicines Evaluation Board (updated)
- Declaration of interests - 39.76 KB | PDF
- Curriculum Vitae - 30.1 KB | PDF
Biopharmaceutics. Research project: ABC Transporters and Scavenger … Organisation: Research Project: “ABC Transporters and Scavenger … van Berkel TJ. Macrophage ABCA2 deletion modulates intracellular … -
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National expert: Serena Marchetti, Medicines Evaluation Board (updated)
- Declaration of interests - 40.57 KB | PDF
- Curriculum Vitae - 32.79 KB | PDF
interactions mediated by the ABC transporter ABCB1 (MDR1, P_glycoprotein). Oncologist … cassette drug transporters ABCB1, ABCG2, and … -
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Applying regulatory science to neonates: launch of the International Neonatal Consortium (INC)
European Medicines Agency, London, UK, from 18/05/2015 to 19/05/2015, Last updated: 08/04/2016Generic Presentation - The ABCs of regulatory science (Susan … Medicines Agency (EMA) The ABCs of Regulatory Science SUSAN … -
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National expert: FULVIO MARSILIO, Ministry Of Health (updated)
- Declaration of interests - 39.34 KB | PDF
- Curriculum Vitae - 58.23 KB | PDF
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Human medicine European public assessment report (EPAR): CellCept
mycophenolate mofetil, Graft Rejection
Date of authorisation: 14/02/1996, Revision: 38, Authorised, Last updated: 17/03/2023 -
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Human medicine European public assessment report (EPAR): Translarna
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,
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, Revision: 22, Authorised, Last updated: 25/04/2023