56 results
Keyword Pemazyre Remove keyword
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Orphan designation: pemigatinib for: Treatment of biliary tract cancer
Date of designation: 24/08/2018, Positive, Last updated: 04/05/2021been authorised in the EU as Pemazyre since 26 March 2021. Expand … Pemazyre Pemazyre pemigatinib … the orphan designation of Pemazyre at the time of marketing … -
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Orphan designation: pemigatinib for: Treatment of myeloid/lymphoid neoplasms with eosinophilia and rearrangement of PDGFRA, PDGFRB, or FGFR1, or with PCM1-JAK
Date of designation: 17/10/2019, Positive, Last updated: 01/02/2021Pemazyre: EPAR Pemazyre: Orphan designation Pemazyre: Orphan designation … Pemazyre Pemazyre pemigatinib … -
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Human medicine European public assessment report (EPAR): Pemazyre (updated)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,
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, Revision: 4, Authorised, Last updated: 09/01/2023
Pemazyre Adenocarcinoma Carcinoma Neoplasms … Pemazyre … EMA/95344/2021 EMEA/H/C/005266 Pemazyre (pemigatinib) An overview … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 2021
CHMP, Last updated: 01/02/2021Pemazyre … -
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Human medicine European public assessment report (EPAR): Keytruda
pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
Date of authorisation: 17/07/2015, Revision: 49, Authorised, Last updated: 06/12/2022 -
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Withdrawn application: Febseltiq (updated)
infigratinib, date of withdrawal: 11/10/2022, Initial authorisation, Last updated: 30/01/2023 -
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Orphan designation: Autologous CD34+ cells transduced with a lentiviral RNA vector that results in integrated cDNA encoding for functional cystinosin for: Treatment of cystinosis
Date of designation: 19/02/2021, Positive, Last updated: 18/05/2022 -
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Orphan designation: Autologous CD34+ hematopoietic stem and progenitor cells transfected with zinc finger nuclease mRNAs SB-mRENH1 and SB-mRENH2 for: Treatment of sickle cell disease
Date of designation: 19/02/2021, Positive, Last updated: 25/04/2022 -
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Orphan designation: Tebentafusp for: Treatment of uveal melanoma
Date of designation: 19/02/2021, Positive, Last updated: 22/04/2022 -
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Orphan designation: 2'-O-methyl phosphorothioate RNA oligonucleotide, 5'-m5CUGm5CUGm5CUGm5CUGm5CUGm5CUGm5CUG-3' for: Treatment of spinocerebellar ataxia
Date of designation: 19/02/2021, Positive, Last updated: 22/02/2022 -
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Orphan designation: 18-(p-[131I]-iodophenyl)octadecyl phosphocholine for: Treatment of lymphoplasmacytic lymphoma
Date of designation: 19/02/2021, Positive, Last updated: 22/02/2022 -
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Orphan designation: Anti-SIGLEC8 IgG1 humanised monoclonal antibody for: Treatment of eosinophilic gastroenteritis
Date of designation: 19/02/2021, Positive, Last updated: 22/02/2022 -
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Orphan designation: (1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromo-3-methylpyridin-2-yl)-5-methyl-2-azabicyclo[3.1.0]hexane-3-carboxamide for: Treatment of paroxysmal nocturnal haemoglobinuria
Date of designation: 19/02/2021, Positive, Last updated: 22/02/2022 -
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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: 22/02/2022 -
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Orphan designation: Rintatolimod for: Treatment of pancreatic cancer
Date of designation: 19/02/2022, Positive, Last updated: 22/02/2022 -
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Orphan designation: (2S)-2-[(2S)-4-cyclohexyl-2-{[(2S)-1-(4-fluorobenzoyl)pyrrolidin-2-yl]formamido}butanamido]-N-(1-{[(1S)-1-{[(1S)-1-({1-[(1-{[2-({1-[(dimethylamino)methyl]cyclobutyl}carbamoyl)ethyl]carbamoyl}-1-methylethyl)carbamoyl]-1-methylethyl}carbamoyl)-3-methylbutyl]carbamoyl}-3-methylbutyl]carbamoyl}-1-methylethyl)-4-methylpentanamide acetate for: Treatment of leishmaniasis
Date of designation: 19/02/2021, Positive, Last updated: 22/02/2022 -
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Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human claudin 18.2 antigen with CD28 and CD3-zeta intracellular signalling domains for: Treatment of gastric cancer
Date of designation: 19/02/2021, Positive, Last updated: 23/02/2022 -
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Orphan designation: Adeno-associated virus serotype 5 containing the human NR2E3 gene for: Treatment of retinitis pigmentosa
Date of designation: 19/02/2021, Positive, Last updated: 23/02/2022 -
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Orphan designation: Dodecyl creatine ester, dodecyl creatine ester hydrochloride for: Treatment of creatine deficiency syndromes
Date of designation: 19/02/2021, Positive, Last updated: 23/02/2022 -
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Orphan designation: 2-[6-(6,7-Dimethoxyquinolin-3-yl)pyridin-3-yl]-N-[3-(1,1,1-trifluoro-2-methylpropan-2-yl)-1,2-oxazol-5-yl]acetamide for: Treatment of medullary thyroid carcinoma
Date of designation: 19/02/2021, Positive, Last updated: 23/02/2022 -
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Orphan designation: Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg-Cys-Asp-Met-Ala-Glu-His-Thr-Glu-Arg-Leu-Lys-Ala-Asn-Asp-Ser-Leu-Lys-Leu-Ser-Gln-Glu-Tyr-Glu-Ser-Ile-NH2 for: Treatment of spinal cord injury
Date of designation: 19/02/2021, Positive, Last updated: 23/02/2022 -
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Orphan designation: Adeno-associated virus serotype 5 containing the human NR2E3 gene for: Treatment of Leber's congenital amaurosis
Date of designation: 19/02/2021, Positive, Last updated: 24/02/2022 -
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Orphan designation: Adeno-associated viral vector serotype 9 expressing codon-optimized human GBA gene for: Treatment of Gaucher disease
Date of designation: 19/02/2021, Positive, Last updated: 02/03/2022 -
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List of medicines under additional monitoring (updated)
Last updated: 25/01/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 November - 1 December 2022
European Medicines Agency, Amsterdam, the Netherlands, from 28/11/2022 to 01/12/2022, Last updated: 29/11/2022