100 results
Keyword Imcivree Remove keyword
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Summary of opinion: Imcivree
setmelanotide, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022Imcivree: Pending EC decision … opinion1 (post authorisation) Imcivree setmelanotide On 21 July … for the medicinal product Imcivree2. The marketing authorisation … -
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Withdrawn application: Imcivree
setmelanotide, date of withdrawal: 22/04/2022, Post-authorisation, Last updated: 28/09/2022Imcivree: Withdrawn application … marketing authorisation for Imcivree (setmelanotide) Rhythm … application for the use of Imcivree to treat obesity and control … -
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Orphan designation: Setmelanotide for: Treatment of Bardet-Biedl syndrome
Date of designation: 21/08/2019, Positive, Last updated: 30/09/2022been authorised in the EU as Imcivree since 2 September 2022. Expand … Imcivree Imcivree setmelanotide Setmelanotide … the orphan designation of Imcivree at the time of marketing … -
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Orphan designation: Setmelanotide for: Treatment of pro-opiomelanocortin deficiency
Date of designation: 14/07/2016, Positive, Last updated: 01/07/2022been authorised in the EU as Imcivree since 16 July 2021. On 14 … Imcivree Imcivree setmelanotide Setmelanotide … the orphan designation of Imcivree at the time of marketing … -
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Orphan designation: Setmelanotide for: Treatment of leptin receptor deficiency
Date of designation: 19/11/2018, Positive, Last updated: 01/07/2022been authorised in the EU as Imcivree since 16 July 2021. On 19 … Imcivree Imcivree setmelanotide Setmelanotide … the orphan designation of Imcivree at the time of marketing … -
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Human medicine European public assessment report (EPAR): Imcivree
Setmelanotide, Obesity
Date of authorisation: 16/07/2021,
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, Revision: 7, Authorised, Last updated: 22/03/2023
Imcivree Nutritional and Metabolic … rised setmelanotide Overview Imcivree is a medicine used to treat … deficiency are rare, and Imcivree was designated an ‘ A medicine … -
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News: New treatment for obesity caused by rare genetic disorders
CHMP, Last updated: 21/05/2021the European Union (EU) for Imcivree (setmelanotide) to support … can start treatment with Imcivree. POMC, PCSK1 or LEPR deficiency … active substance contained in Imcivree, works by activating a pathway … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2022
CHMP, Last updated: 22/07/2022Imcivree … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 May 2021
CHMP, Last updated: 21/05/2021Imcivree … -
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Orphan designation: H-Lys-Lys-Gly-Asp-Asn-Ile-Met-Val-Thr-Phe-Arg-Asn-Gln-Ala-Ser-Arg-Pro-Tyr-Gly-Lys-Lys-OH for: Treatment of haemophilia A (updated)
Date of designation: 10/08/2022, Positive, Last updated: 07/06/2023 -
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Orphan designation: Bomedemstat ditosilate for: Treatment of essential thrombocythaemia
Date of designation: 21/06/2021, Positive, Last updated: 02/05/2023 -
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Orphan designation: Streptococcus pyogenes, group A, type 3, strain Su, inactivated for: Treatment of lymphatic malformations
Date of designation: 16/05/2022, Positive, Last updated: 04/04/2023 -
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Orphan designation: Humanised IgG2 monoclonal antibody against TNFSF13 for: Treatment of primary IgA nephropathy
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: L-ergothioneine for: Treatment of cystinuria
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Tislelizumab for: Treatment of nasopharyngeal cancer
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Adeno-associated virus serotype 9 expressing human CLN5 for: Treatment of neuronal ceroid lipofuscinosis
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Allogenic placenta-derived mesenchymal stromal cells secretome for: Treatment of pre-eclampsia
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: imatinib for: Treatment of pulmonary arterial hypertension
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: (S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropane-2-yl)-1H-pyrazole-4-carboxamide for: Treatment of mantle cell lymphoma
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Adeno-associated virus serotype 9 containing the human FXN gene isoform 1 for: Treatment of Friedreich's ataxia
Date of designation: 21/06/2021, Withdrawn, Last updated: 11/05/2022 -
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Orphan designation: Hydrocortisone hydrogen succinate for: Prevention of bronchopulmonary dysplasia
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: melatonin for: Prevention of retinopathy of prematurity
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Humanised monoclonal antibody derivative against fibroblast growth factor receptor 3 for: Treatment of achondroplasia
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: H-D-valyl1-D-alanyl-D-glutamyl-D-alanyl-D-arginyl5-D-glutamyl-D-glutamyl-D-leucyl-D-glutamyl-D-arginyl10-D-leucyl-D-glutamyl-D-alanyl-D-arginyl-D-leucyl15-glycyl-D-glutaminyl-D-alanyl-D-arginyl-glycyl20-D-glutamyl-D-leucyl-D-lysyl-D-lysyl-D-tryptophyl25-D-lysyl-D-methionyl-D-arginyl-D-arginyl-D-asparaginyl30-D-glutaminyl-D-phenylalanyl-D-tryptophyl-D-leucyl-D-lysyl35-D-leucyl-D-glutaminyl-D-arginine for: Treatment of glioma
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Adeno-associated viral vector LK03 encoding human methylmalonyl-CoA mutase for: Treatment of methylmalonic acidaemia
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022