4061 results
Keyword Ferro-Grad Folic Remove keyword
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Withdrawn application: Neocepri
date of withdrawal: 16/05/2014, Initial authorisation, Last updated: 14/08/2014authorisation) Neocepri folic acid On 20 March 2014 … substance of Neocepri is folic acid to be administered … application for Neocepri (folic acid) 30 Churchill … -
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Orphan designation: folic acid for: Diagnosis of positive folate-receptor status in ovarian cancer
Date of designation: 10/09/2012, Withdrawn, Last updated: 07/02/2017folic acid … opinion on orphan designation Folic acid to be used with N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine … opinion on orphan designation Folic acid to be used with N-[4-[[(2-amino-3,4-dihydro-4-oxo-6- pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta- alanyl-L-alpha-aspartyl-L-cysteine … -
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Opinion/decision on a Paediatric investigation plan (PIP): folic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Diagnostic
PIP number: EMEA-001321-PIP01-12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection, Solution for infusion
Decision date: 23/10/2012, Last updated: 27/11/2012, Compliance check: XActive substance folic acid Therapeutic area Diagnostic … product specific waiver for folic acid (EMEA-001321-PIP01-12 … product specific waiver for folic acid (EMEA-001321-PIP01-12 … -
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Orphan designation: N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine, folic acid for: Diagnosis of positive folate-receptor status in ovarian cancer
Date of designation: 09/02/2012, Withdrawn, Last updated: 12/11/2012alpha-aspartyl-L-cysteine / folic acid … N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine and folic acid 7 Westferry Circus … designation N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D- gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine and folic acid for the diagnosis of … -
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National expert: Mary O'Grady, Health Products Regulatory Authority (updated)
- Declaration of interests - 39.31 KB | PDF
- Curriculum Vitae - 23.58 KB | PDF
Mary O'Grady … Mary O'Grady … Vitae Personal information Mary O'Grady Work experience … -
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High-grade glioma expert group
London, UK, 03/12/2010, Last updated: 06/07/2011High-grade glioma expert group … treat children with high-grade glioma, a disease with a … report on the paediatric high-grade glioma medicines expert workshop … -
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Suitability of the graduation of delivery devices for liquid dosage forms - Scientific guideline
Last updated: 01/02/2005Suitability of the graduation of delivery devices for liquid … Suitability of the graduation of delivery devices for liquid … Guideline Suitability Graduation Delivery Devices …
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Direct healthcare professional communication (DHPC): Important information on Gliolan (5-aminolevulinic acid, 5-ALA): What to do in case of delayed surgery and information on fluorescence in non high-grade glioma
Active substance: 5-aminolevulinic acid hydrochloride, DHPC type: Type II variation, Last updated: 01/12/2020fluorescence in non high-grade glioma Glioma … fluorescence in non high-grade glioma … -
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Human medicine European public assessment report (EPAR): Folotyn
Pralatrexate, Lymphoma, T-Cell
Date of refusal: 21/06/2012,
, Refused, Last updated: 11/07/2012
expected to take the place of folic acid and attach to an enzyme … together with vitamin B12 and folic acid supplements (to compensate … expected to take the place of folic acid and attach to an enzyme … -
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Human medicine European public assessment report (EPAR): Pemetrexed medac
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 26/11/2015,
, Revision: 8, Authorised, Last updated: 09/08/2022
reduces inflammation) and folic acid (a type of vitamin … -
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Human medicine European public assessment report (EPAR): Methylthioninium chloride Proveblue
methylthioninium chloride, Methemoglobinemia
Date of authorisation: 06/05/2011, Revision: 25, Authorised, Last updated: 15/12/2022an atom of iron in the ‘ferrous’ form (Fe 2+ ). Exposure … converting them into the normal ferrous form. What benefits of Methylthioninium … an atom of iron in the ‘ferrous’ form (Fe2+). Exposure … -
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Human medicine European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane)
Para-aminosalicylic acid, Tuberculosis
Date of authorisation: 07/04/2014,, Revision: 11, Authorised, Last updated: 26/04/2023
used by the bacteria to make folic acid needed for new bacteria … in the processes that make folic acid, para-aminosalicylic … acid reduces the amount of folic acid produced and thereby … -
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Orphan designation: Vatiquinone for: Treatment of Friedreich's ataxia
Date of designation: 26/03/2021, Positive, Last updated: 19/01/2022death by a process called ferroptosis. Vatiquinone is an inhibitor … stress and inflammation in ferroptosis. By inhibiting 15-LO, vatiquinone … -
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Veterinary medicine European public assessment report (EPAR): Palladia
toceranib, Dogs
Date of authorisation: 23/09/2009, Revision: 10, Authorised, Last updated: 30/03/2021are severe in character (grade 2 or 3), have come back … of non-resectable Patnaik grade-II (intermediate grade) or -III (high grade), recurrent, cutaneous mast-cell … are severe in character (grade 2 or 3), have come back … -
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Orphan designation: Vatiquinone for: Treatment of Alpers-Huttenlocher syndrome
Date of designation: 10/12/2021, Positive, Last updated: 13/04/2022which in turn can induce ferroptosis (a type of cell death dependent … stress and inflammation in ferroptosis. By inhibiting 15-LO, vatiquinone … -
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Orphan designation: 2-(2-{[2-(1h-benzimidazol-2-yl)ethyl]amino}ethyl)-n-[(3-fluoropyridin-2-yl)methyl]-1,3-oxazole-4-carboxamide trihydrochloride for: Treatment of sickle cell disease
Date of designation: 19/02/2021, Positive, Last updated: 22/02/2022action of a protein called ferroportin, which transports iron into … haemoglobin in red blood cells. Ferroportin inhibition (blocking) is … -
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Orphan designation: Vatiquinone for: Treatment of mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes
Date of designation: 24/02/2022, Positive, Last updated: 28/04/2022which in turn can induce ferroptosis (a type of cell death dependent … stress and inflammation in ferroptosis. By inhibiting 15-LO, vatiquinone … -
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Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)
pemetrexed ditromethamine, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 24/04/2017,, Revision: 7, Withdrawn, Last updated: 29/07/2021
peutic group ANTIMETABOLITES Folic acid analogues Therapeutic … reduces inflammation) and folic acid (a type of vitamin … -
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CHMP opinions on consultation procedures (updated)
Last updated: 16/05/2023haemostatic matrix kit - Ferrosan …
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National expert: Marte-Helene Bjork, null (updated)
- Declaration of interests - 44.71 KB | PDF
- Curriculum Vitae - 34.2 KB | PDF
With Epilepsy and High_Dose Folic Acid Use During Pregnancy … November 2022;79(11) _ High dose folic acid associated with childhood … Tomson, Marte_Helene Bjørk. Folic acid and risk of preterm … -
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Human medicine European public assessment report (EPAR): Breyanzi (updated)
CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
Date of authorisation: 04/04/2022,
, Revision: 1, Authorised, Last updated: 25/05/2023
lymphoma (DLBCL); high-grade B-cell lymphoma (HGBCL); … PMBCL); follicular lymphoma grade 3B (FL3B). Breyanzi can be … lymphoma (DLBCL); • high-grade B-cell lymphoma (HGBCL … -
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Human medicine European public assessment report (EPAR): Targretin
bexarotene, Lymphoma, T-Cell, Cutaneous
Date of authorisation: 29/03/2001, Revision: 23, Authorised, Last updated: 26/01/2022measured by the doctor’s grading of improvement, as well as … according the doctor’s grading. The response rates according … EMA/234177/2018 Page 2/2 grading of improvement, as well as … -
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Orphan designation: N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine (etarfolatide) for: Diagnosis of positive folate-receptor status in ovarian cancer
Date of designation: 10/09/2012, Withdrawn, Last updated: 07/12/2021N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine to be used with folic acid (etarfolatide) for … called folate receptor which folic acid (a vitamin required … The medicine is made up of folic acid attached to another … -
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Human medicine European public assessment report (EPAR): Eladynos
abaloparatide, Osteoporosis
Date of refusal: 07/01/2019, Refused, Last updated: 14/02/2019is naturally broken down. Gradually, the bones become thin and … is naturally broken down. Gradually, the bones become thin and … is naturally broken down. Gradually, the bones become thin and … -
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Human medicine European public assessment report (EPAR): Pemetrexed Krka
pemetrexed disodium, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/05/2018,, Revision: 6, Authorised, Last updated: 22/02/2023
reduces inflammation) and folic acid (a type of vitamin … reduces inflammation) and folic acid (a …