74 results
Keyword Deferoxamine Remove keyword
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Orphan designation: Deferoxamine mesilate for: Treatment of traumatic spinal cord injury
Date of designation: 20/10/2004, Withdrawn, Last updated: 08/10/2013Deferoxamine mesilate Overview Please … Biopharmaceuticals GmbH, Germany, for deferoxamine mesilate for the treatment … information in the spinal cord. Deferoxamine binds to iron, one of the … -
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Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate), histidine, tryptophan, aspartic acid, n-acetyl-histidine (monohydrate), glycine, alpha-ketoglutaric acid, arginine, potassium chloride, magnesium chloride (hexahydrate), calcium chloride (dihydrate), sodium chloride, alanine, 3,4-dimethoxy-N-methylbenzohydroxamic acid (Custodiol-N)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002735-PIP03-20, Pharmaceutical form(s): Solution for organ preservation
Decision date: 10/05/2021, Last updated: 14/02/2022, Compliance check: XActive substance Deferoxamine (mesylate) histidine tryptophan … granting of a deferral for deferoxamine (mesylate) / histidine … granting of a deferral for deferoxamine (mesylate) / histidine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate), histidine, tryptophan, aspartic acid, n-acetyl-histidine (monohydrate), glycine, alpha-ketoglutaric acid, arginine, potassium chloride, magnesium chloride (hexahydrate), calcium chloride (dihydrate), sodium chloride, alanine, 3,4-dimethoxy-N-methylbenzohydroxamic
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002735-PIP01-19, Route(s) of administration: Intracoronary use, Pharmaceutical form(s): Concentrate and solvent for solution for infusion
Decision date: 09/06/2021, Last updated: 26/04/2022, Compliance check: XActive substance Deferoxamine (mesylate) histidine tryptophan … granting of a deferral for deferoxamine (mesylate) / histidine … granting of a deferral for deferoxamine (mesylate) / histidine … -
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Human medicine European public assessment report (EPAR): Ferriprox
Deferiprone, beta-Thalassemia; Iron Overload
Date of authorisation: 25/08/1999, Revision: 31, Authorised, Last updated: 13/12/2022patients compared Ferriprox with deferoxamine, another iron chelator, over … iron chelator, over 2 years. Deferoxamine was given by injection under … to increase more than in deferoxamine-treated patients. In another study … -
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Human medicine European public assessment report (EPAR): Exjade
deferasirox, beta-Thalassemia; Iron Overload
Date of authorisation: 28/08/2006,
, Revision: 51, Authorised, Last updated: 22/12/2022
blood transfusions, when deferoxamine (another medicine used to … blood transfusions, when deferoxamine cannot be used or is inadequate … blood transfusions, when deferoxamine cannot be used or is inadequate … -
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Human medicine European public assessment report (EPAR): Deferasirox Accord
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 09/01/2020,
, Revision: 3, Authorised, Last updated: 08/02/2022
blood transfusions, when deferoxamine (another medicine used to … blood transfusions, when deferoxamine cannot be used or is inadequate … blood transfusions, when deferoxamine cannot be used or is inadequate … -
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Human medicine European public assessment report (EPAR): Deferasirox Mylan (updated)
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 26/09/2019,, Revision: 8, Authorised, Last updated: 10/01/2023
blood transfusions, when deferoxamine (another medicine used to … blood transfusions, when deferoxamine cannot be used or is inadequate … blood transfusions, when deferoxamine cannot be used or is inadequate … -
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National expert: Jean-marie Colet, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 27.26 KB | PDF
Reperfusion Injury by Conjugated Deferoxamine. Magnetic Resonance in Medicine … -
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National expert: Kathrine Just Andersen, Danish Medicines Agency (updated)
- Declaration of interests - 80.43 KB | PDF
- Curriculum Vitae - 18.72 KB | PDF
V, Romero-Ramos M. Chronic deferoxamine induces changes in alpha-synuclein … -
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Orphan designation: 4-(3,5-Bis(hydroxy-phenyl)-1,2,4) triazol-1-yl) benzoic acid for: Treatment of chronic iron overload requiring chelation therapy
Date of designation: 13/03/2002, Expired, Last updated: 30/09/2016to blood transfusions when deferoxamine therapy is contraindicated … to blood transfusions when deferoxamine therapy is contraindicated … -
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Human medicine European public assessment report (EPAR): Deferiprone Lipomed
Deferiprone, Iron Overload; beta-Thalassemia
Date of authorisation: 19/09/2018,, Revision: 6, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Byooviz (updated)
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021,, 
, Revision: 5, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Zynteglo
Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,
, , 
, 
, Revision: 5, Withdrawn, Last updated: 30/11/2022
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2012
CHMP, Last updated: 16/11/2012requiring chelation therapy when deferoxamine therapy is contraindicated … -
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Human medicine European public assessment report (EPAR): Ranivisio
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 25/08/2022,, , Revision: 1, Authorised, Last updated: 05/10/2022
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Veterinary medicine European public assessment report (EPAR): Baycox Iron
Iron(iii) ion, toltrazuril, Pigs (piglets)
Date of authorisation: 20/05/2019, Authorised, Last updated: 07/04/2020as chelating agents (e.g. deferoxamine) can be used. 4.11 Withdrawal … -
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Human medicine European public assessment report (EPAR): Evrysdi
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,, 
, Revision: 2, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Zebinix
eslicarbazepine acetate, Epilepsy
Date of authorisation: 21/04/2009, Revision: 31, Authorised, Last updated: 14/03/2022 -
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Human medicine European public assessment report (EPAR): Mepact
mifamurtide, Osteosarcoma
Date of authorisation: 06/03/2009, Revision: 16, Authorised, Last updated: 17/06/2020 -
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National expert: Holger Cario, European Medicines Agency (updated)
- Declaration of interests - 81.49 KB | PDF
- Curriculum Vitae - 33.05 KB | PDF
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National expert: Konstantinos Konstantopoulos, National Organization for Medicines (updated)
- Declaration of interests - 80.1 KB | PDF
- Curriculum Vitae - 64.98 KB | PDF
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National expert: Georgios Papazisis, National Organization for Medicines (updated)
- Declaration of interests - 80.18 KB | PDF
- Curriculum Vitae - 37.77 KB | PDF
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Referral: Zynteglo
betibeglogene autotemcel, associated names: Zynteglo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 22/07/2021, EC decision date: 16/09/2021, Last updated: 08/07/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Exjade, deferasirox
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001103-PIP01-10-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Film-coated tablet, Granules
Decision date: 30/06/2016, Last updated: 21/12/2016, Compliance check: V, 14/10/2016to blood transfusions when deferoxamine therapy is contraindicated … -
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PDCO: Agendas, minutes and reports (updated)
Last updated: 17/01/2023