579 results
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,
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, Revision: 3, Authorised, Last updated: 09/04/2021
prela (previously Pretomanid FGK) Tuberculosis, Multidrug-Resi … prela (previously Pretomanid FGK) … prela (previously Pretomanid FGK) pretomanid … -
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Withdrawn application: Memantine FGK
memantine, date of withdrawal: 18/12/2012, Initial authorisation, Last updated: 10/04/2013Memantine FGK: Withdrawn application … application for Memantine FGK (memantine) On 10 January … memantine) On 10 January 2013, FGK Representative Service GmbH … -
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Orphan designation: (S)-2-nitro-6-(4-trifluoromethoxy)benzyloxy)-6,7-dihydro-5H-imidazo[2,1-b] [1,3] oxazine (pretomanid) for: Treatment of tuberculosis
Date of first decision: 29/11/2007, Positive, Last updated: 09/12/2020sponsorship was transferred to FGK Representative Service GmbH … authorised in the EU as Pretomanid FGK since 31 July 2020. The … prela (previously Pretomanid FGK) Dovprela (previously Pretomanid … -
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Press release: FGK Representative Service GmbH withdraws its marketing-authorisation application for Memantine FGK (memantine)
Last updated: 11/01/2013FGK Representative Service GmbH … application for Memantine FGK (memantine … been formally notified by FGK Representative Service GmbH … -
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Human medicine European public assessment report (EPAR): Crysvita
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 7, Authorised, Last updated: 18/02/2021
levels of a protein called FGF23 which causes the kidneys … recognise and attach to the FGF23 protein. By attaching to the FGF23 protein, the medicine blocks … levels of a protein called FGF23 which causes the kidneys … -
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Human medicine European public assessment report (EPAR): Pemazyre (new)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,, , , Authorised, Last updated: 04/05/2021
receptor (target) called FGFR2 on their surface. Pemazyre … growth factor receptors (FGFRs). Abnormal FGFRs are found on the surface … tract cancer with abnormal FGFR2. Around 37% of patients had … -
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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 first decision: 17/10/2019, Positive, Last updated: 01/02/2021rearrangement of PDGFRA, PDGFRB, or FGFR1, or with PCM1-JAK2. Expand … rearrangement of PDGFRA, PDGFRB, or FGFR1, or with PCM1-JAK2? Myeloid/lymphoid … rearrangement of PDGFRA, PDGFRB, or FGFR1, or with PCM1-JAK2 are a group … -
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Orphan designation: Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 (burosumab) for: Treatment of X-linked hypophosphataemia
Date of first decision: 15/10/2014, Positive, Last updated: 22/10/2018fibroblast growth factor 23 (or FGF23). FGF23 signals the kidneys to stop … bloodstream. If levels of FGF23 are high, the kidneys stop … recognise and attach to the FGF23 protein. By attaching to the … -
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Human medicine European public assessment report (EPAR): Kolbam
cholic acid, Metabolism, Inborn Errors
Date of authorisation: 20/11/2015,
, Revision: 14, Withdrawn, Last updated: 15/07/2020
Therapeutic indication Cholic Acid FGK is indicated for the treatment … -
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Human medicine European public assessment report (EPAR): Kisplyx (updated)
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, 
, Revision: 14, Authorised, Last updated: 22/04/2021
receptors (such as VEGF, FGFR, PDGF, KIT and RET receptors … receptors (such as VEGF, FGFR, PDGF, KIT and RET receptors … -
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Human medicine European public assessment report (EPAR): Unituxin
Dinutuximab, Neuroblastoma
Date of authorisation: 14/08/2015, Revision: 3, Withdrawn, Last updated: 28/04/2017Road Chertsey Surrey KT16 9FG United Kingdom … -
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Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide) for: Treatment of achondroplasia
Date of first decision: 24/01/2013, Positive, Last updated: 22/02/2019growth-factor receptor 3 (FGFR3). Patients who have inherited … patients with only one defective FGFR3 gene, achondroplasia causes … achondroplasia, the gene FGFR3 is permanently 'switched … -
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Orphan designation: Burosumab for: Treatment of phosphaturic mesenchymal tumour
Date of first decision: 16/04/2018, Positive, Last updated: 17/05/2018fibroblast growth factor 23 (FGF23), which cause the body … mesenchymal tumour, excess FGF23 causes the kidneys to stop … to recognise and attach to FGF23. By attaching to … -
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Orphan designation: N-{2-[(6-{[(2,6-dichloro-3,5-dimethoxyphenyl)carbamoyl](methyl)amino}pyrimidin-4-yl)amino]-5-(4-ethylpiperazin-1-yl)phenyl}prop-2-enamide for: Treatment of hepatocellular carcinoma
Date of first decision: 23/08/2017, Positive, Last updated: 11/08/2020growth factor receptor 4 (FGFR4). In hepatocellular carcinoma … hepatocellular carcinoma, FGFR4 is overactive and is involved … cancer cells. By blocking FGFR4, this medicine is expected … -
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National expert: Fabrizio Galliccia, Italian Medicines Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 16.5 KB | PDF
PDF icon application/pdf fgalliccia_CV_en.pdf Declaration of interests … PDF icon application/pdf fgalliccia_DI_en.pdf … -
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National expert: Franca Gauly, Paul Ehrlich Institute (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 17.17 KB | PDF
PDF icon application/pdf fgauly_CV_en.pdf Declaration of interests … PDF icon application/pdf fgauly_DI_en.pdf … -
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Orphan designation: Soluble recombinant human fibroblast growth factor receptor 3 for: Treatment of achondroplasia
Date of first decision: 27/02/2017, Positive, Last updated: 31/03/2017growth-factor receptor 3 (FGFR3). Patients who have inherited … patients with only one defective FGFR3 gene, achondroplasia causes … growth factors attach to FGFR3 receptors on cells to regulate … -
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Human medicine European public assessment report (EPAR): Dzuveo
sufentanil citrate, Pain
Date of authorisation: 25/06/2018, Revision: 1, Authorised, Last updated: 08/10/2019citratesufentanilPainN01AH03 Publication details >FGK Representative Service GmbH1 … -
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Orphan designation: C-type natriuretic peptide conjugated to multi-arm polyethylene glycol carrier through a cleavable linker for: Treatment of achondroplasia
Date of first decision: 27/07/2020, Positive, Last updated: 19/11/2020growth-factor receptor 3 (FGFR3). Patients who have inherited … patients with only one defective FGFR3 gene, achondroplasia causes … -
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Human medicine European public assessment report (EPAR): Vargatef
nintedanib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/11/2014, Revision: 14, Authorised, Last updated: 08/03/2021receptors (such as VEGF, FGF and PDGF receptors) on the … receptors (such as VEGF, FGF and PDGF receptors) on the … -
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Orphan designation: 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester for: Treatment of infantile neuroaxonal dystrophy
Date of first decision: 26/02/2019, Positive, Last updated: 09/04/2019the European Commission to FGK Representative Service GmbH … -
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Orphan designation: Infigratinib for: Treatment of cholangiocarcinoma
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020growth factor receptors (FGFRs). These mutations are thought … medicine blocks the action of FGFR 1, 2, and 3. By blocking … and 3. By blocking these FGFRs, the medicine is expected … -
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National expert: Ferran Torres, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 81.33 KB | PDF
- Curriculum Vitae - 51.73 KB | PDF
Cholangiocarcinoma for Subjects with FGFR2 Gene Fusion + Torres … -
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National expert: Wilhelmus Petrus Johannes (Wim) Witjes, European Medicines Agency (updated)
- Declaration of interests - 82.13 KB | PDF
- Curriculum Vitae - 40.76 KB | PDF
01/2018-(current) Incyte Pemigatinib FGFR3 inhibition Urothelial Cancer … -
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Orphan designation: 5-amino-1-(2-methyl-1H-benzo[d]imidazol-5-yl)-1H-pyrazol-4-yl 1H-indol-2-yl ketone mono[(S)-2-hydroxysuccinate] for: Treatment of biliary tract cancer
Date of first decision: 16/10/2017, Withdrawn, Last updated: 11/12/2020growth factor receptors (FGFRs FGFRs are found on the surface … the tyrosine kinases in the FGFR receptors, this medicine … growth factor receptors (FGFRs FGFRs are found on the surface …