23 results
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Human medicine European public assessment report (EPAR): Zynquista
Sotagliflozin, Diabetes Mellitus, Type 1
Date of authorisation: 26/04/2019,
, Revision: 3, Withdrawn, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Forcaltonin
Recombinant salmon calcitonin, Hypercalcemia; Osteitis Deformans; Bone Resorption
Date of authorisation: 11/01/1999, Withdrawn, Last updated: 20/11/2008 -
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Human medicine European public assessment report (EPAR): Invokana
canagliflozin, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2013, Revision: 20, Authorised, Last updated: 04/03/2022 -
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National expert: Johan Verhaeghe, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 80.4 KB | PDF
- Curriculum Vitae - 48.63 KB | PDF
p.) 12. Verhaeghe J., Bouillon R. Calciotropic hormones during reproduction … -
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National expert: Manuel Campos Toimil, European Medicines Agency (updated)
- Declaration of interests - 80.05 KB | PDF
- Curriculum Vitae - 34.81 KB | PDF
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National expert: Lorenzo José Fraile Sauce, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 80.48 KB | PDF
- Curriculum Vitae - 45.5 KB | PDF
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National expert: Astrid Thomas, European Medicines Agency (updated)
- Declaration of interests - 79.97 KB | PDF
- Curriculum Vitae - 55.73 KB | PDF
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Referral: Calcitonins
calcitonin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/11/2002, EC decision date: 12/06/2003, Last updated: 02/03/2004Tiburtina, 1004 IT-00156 Roma Calciosint 50 IU/ ml 100 IU/ ml Solution … Santa Palomba Pomezia Calcioton 50 IU/ml Solution for injection … use Ampoule 1 ml 5 Calcioton 100 IU/ml Solution for injection … -
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Orphan designation: Acamprosate calcium for: Treatment of fragile X syndrome
Date of designation: 15/10/2014, Positive, Last updated: 03/11/2022X-szindróma kezelésére Italian Calcio acamprosate Trattamento della … fragilnega kromosoma X Spanish Calcio acamprosato Tratamiento del … -
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Referral: Calcitonin
calcitonin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/07/2012, EC decision date: 13/02/2013, Last updated: 19/07/2013 -
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Orphan designation: Immunoglobulin G1, anti-(human tumour-associated calcium signal transducer 2)(human-Mus musculus monoclonal hRS7 heavy chain), disulfide with human-Mus musculus monoclonal hRS7 κ-chain, dimer, hexakis(thioether) with (4S)-4-[[[[4-[[(2S)-2-(4-aminobutyl)-2-[[2-[2-[[26-[4-[[[[4-[(3-mercapto-2,5-dioxo-1-pyrrolidinyl)methyl]cyclohexyl]carbonyl]amino]methyl]-1H-1,2,3-triazol-1-yl]-3,6,9,12,15,18,21,24-octaoxahexacos-1-yl]amino]-2-oxoethoxy]acetyl]amino]-1-oxoethyl]amino]phenyl]methoxy]carbonyl]oxy]-4,11-diethyl-9-hydroxy-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-dione (sacituzumab govitecan) for: Treatment of pancreatic cancer
Date of designation: 15/10/2014, Positive, Last updated: 28/07/2021 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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National expert: Aldo Pietro Maggioni, European Medicines Agency (updated)
- Declaration of interests - 82.36 KB | PDF
- Curriculum Vitae - 80.77 KB | PDF
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National expert: Geert Verbeke, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 80.22 KB | PDF
- Curriculum Vitae - 62.51 KB | PDF
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Orphan designation: Heparin-activated recombinant human fibroblast growth factor 1 (on a biodegradable device made from alpha-calcium sulfate hemihydrate) for: Treatment of traumatic spinal cord injury
Date of designation: 27/07/2010, Withdrawn, Last updated: 03/02/2021 -
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Orphan designation: S-acetyl-(S)-4'-phosphopantetheine, calcium salt for: Treatment of pantothenate-kinase-associated neurodegeneration
Date of designation: 28/04/2016, Positive, Last updated: 02/12/2019 -
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Guidance documents
Last updated: 19/07/2022 -
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Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Last updated: 12/09/2022 -
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News: EMA's medical literature monitoring enters into full operation
Last updated: 01/09/2015 -
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News: Safety monitoring of medicines: EMA to screen medical literature for 400 active substance groups
Last updated: 12/05/2015 -
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Press release: Committee for Proprietary Medicinal Products (CPMP) 45th plenary meeting
Last updated: 01/02/1999 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2018
European Medicines Agency, London, UK, from 11/06/2018 to 14/06/2018, Last updated: 10/08/2018 -
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Physical frailty: instruments for baseline characterisation of older populations in clinical trials - Scientific guideline
Last updated: 22/02/2018