722 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: 5, Authorised, Last updated: 23/02/2022
prela (previously Pretomanid FGK) Infections Bacterial Infections … pretomanid Overview Pretomanid FGK is a medicine for treating … side effects. Pretomanid FGK is used together with bedaquiline … -
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Withdrawn application: Sildenafil FGK
sildenafil, date of withdrawal: 19/07/2021, Initial authorisation, Last updated: 05/10/2021Sildenafil FGK: Withdrawn application … authorisation of Sildenafil FGK (sildenafil FGK Representative Service GmbH … authorisation of Sildenafil FGK for the treatment of adult … -
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Withdrawn application: Memantine FGK
memantine, date of withdrawal: 18/12/2012, Initial authorisation, Last updated: 10/04/2013Memantine FGK: Withdrawn application … application for Memantine FGK (memantine) On 10 January … memantine) On 10 January 2013, FGK Representative Service GmbH … -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 designation: 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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Orphan designation: (S)-12-fluoro-4-(2-methylpyridin-3-yl)-7a,8,13,14-tetrahydro-7H-[1,2,4]triazolo[4',3':1,6]pyrido[3,2-b]benzofuro[4,3-fg][1,4]oxazonine for: Treatment of sickle cell disease (new)
Date of designation: 16/03/2022, Positive, Last updated: 16/06/20226]pyrido[3,2-b]benzofuro[4,3-fg][1,4]oxazonine Overview This … 6]pyrido[3,2-b]benzofuro[4,3-fg][1,4]oxazonine … -
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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 … FGK Representative Service GmbH … -
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Human medicine European public assessment report (EPAR): Voxzogo
Vosoritide, Achondroplasia
Date of authorisation: 26/08/2021,, , Revision: 1, Authorised, Last updated: 24/02/2022
growth-factor receptor 3 (FGFR3). The mutation affects growth … growth-factor receptor 3 (FGFR3). The mutation affects growth … with achondroplasia, the FGFR3 gene, which regulates growth … -
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Human medicine European public assessment report (EPAR): Pemazyre (updated)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,, , , Revision: 3, Authorised, Last updated: 15/06/2022
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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Human medicine European public assessment report (EPAR): Crysvita
Burosumab, Hypophosphatemia, Familial; Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 9, Authorised, Last updated: 10/12/2021
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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Summary of opinion: Crysvita (new)
burosumab, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022fibroblast growth factor 23 (FGF23)-related hypophosphataemia … fibroblast growth factor 23 (FGF23)-related hypophosphataemia … indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced … -
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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: 01/02/2021rearrangement of PDGFRA, PDGFRB, or FGFR1, or with PCM1-JAK … -
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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: Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 (burosumab) for: Treatment of X-linked hypophosphataemia
Date of designation: 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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Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide) for: Treatment of achondroplasia
Date of designation: 24/01/2013, Positive, Last updated: 09/09/2021growth-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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Human medicine European public assessment report (EPAR): Kisplyx (updated)
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,
, Revision: 17, Authorised, Last updated: 17/06/2022
receptors (such as VEGF, FGFR, PDGF, KIT and RET receptors … receptors (such as VEGF, FGFR, PDGF, KIT and RET receptors … -
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Orphan designation: Burosumab for: Treatment of phosphaturic mesenchymal tumour
Date of designation: 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 designation: 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: Nuno Sousa, National Authority of Medicines and Health Products, I.P. (updated)
- Declaration of interests - 85.13 KB | PDF
- Curriculum Vitae - 16.82 KB | PDF
Português de Oncologia do Porto, FG (Portugal) Head of Gastrointestinal … Português de Oncologia do Porto, FG (Portugal) Oversight and … Português de Oncologia do Porto, FG (Portugal) Clinical and … -
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Orphan designation: Soluble recombinant human fibroblast growth factor receptor 3 for: Treatment of achondroplasia
Date of designation: 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): Vargatef
nintedanib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/11/2014, Revision: 17, Authorised, Last updated: 07/12/2021receptors (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: C-type natriuretic peptide conjugated to multi-arm polyethylene glycol carrier through a cleavable linker for: Treatment of achondroplasia
Date of designation: 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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Orphan designation: pemigatinib for: Treatment of biliary tract cancer
Date of designation: 24/08/2018, Positive, Last updated: 04/05/2021growth factor receptors (FGFRs FGFRs are found on the surface … blocking the tyrosine kinases in FGFRs, pemigatinib is expected to … -
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National expert: Franca Gauly, Paul Ehrlich Institute (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 17.35 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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Withdrawn application: Livmarli
maralixibat, date of withdrawal: 23/08/2021, Initial authorisation, Last updated: 17/12/2021FGK Representative Service GmbH … maralixibat chloride) FGK Representative Service GmbH … -
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Human medicine European public assessment report (EPAR): Lenvima
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,, , Revision: 16, Authorised, Last updated: 01/12/2021
receptors (such as VEGF, FGFR and RET receptors) in cancer … receptors (such as VEGF, FGFR and RET receptors) in cancer …