32 results
Keyword sotagliflozin Remove keyword
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Human medicine European public assessment report (EPAR): Zynquista
Sotagliflozin, Diabetes Mellitus, Type 1
Date of authorisation: 26/04/2019,
, Revision: 2, Authorised, Last updated: 27/10/2020
sotagliflozin … Zynquista sotagliflozin Sotagliflozin … -
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Opinion/decision on a Paediatric investigation plan (PIP): Sotagliflozin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001517-PIP02-14-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules, Tablets
Decision date: 30/10/2017, Last updated: 30/01/2020, Compliance check: XActive substance Sotagliflozin Therapeutic area Endocrinology … paediatric investigation plan Sotagliflozin for treatment of type 1 diabetes … Investigation Plan* (PIP) for sotagliflozin for the the treatment of … -
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Opinion/decision on a Paediatric investigation plan (PIP): Sotagliflozin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001517-PIP01-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 09/08/2017, Last updated: 02/10/2017, Compliance check: XActive substance Sotagliflozin Therapeutic area Endocrinology … paediatric investigation plan Sotagliflozin for treatment of type 2 diabetes … Investigation Plan* (PIP) for sotagliflozin for treatment of type 2 diabetes … -
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National expert: Maurizio Volterrani, Italian Medicines Agency (updated)
- Declaration of interests - 83.5 KB | PDF
- Curriculum Vitae - 19.67 KB | PDF
Failure 11/2018-09/2020 SANOFI Sotagliflozin/SAR439954 Types 2 Diabetes and Heart Failure … -
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Press release: New add-on treatment to insulin for treatment of certain patients with type 1 diabetes
CHMP, Last updated: 01/03/2019positive opinion for Zynquista (sotagliflozin) intended as an adjunct to … benefit of treatment with sotagliflozin in patients with type 1 diabetes … -
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National expert: Concepcion Gimenez Rebollo, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 84.22 KB | PDF
- Curriculum Vitae - 18.95 KB | PDF
Ingelheim, Oxford SOTA Bone (Sotagliflozin) - Sanofi DAPA CKD (Dapagliflozin … LMC Manna Research, Sanofi Sotagliflozin To demonstrate the superiority … demonstrate the superiority of sotagliflozin dose 1 versus placebo with … -
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National expert: Jochen Seufert, European Medicines Agency (updated)
- Declaration of interests - 82.35 KB | PDF
- Curriculum Vitae - 45.97 KB | PDF
01/2018-(current) Sanofi Aventis Sotagliflozin Type 2 Diabetes mellitus … -
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National expert: Caterina Conte, Italian Medicines Agency (updated)
- Declaration of interests - 80.01 KB | PDF
- Curriculum Vitae - 25.67 KB | PDF
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 February 2019
CHMP, Last updated: 01/03/2019sotagliflozin), intended as an adjunct … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 23-26 November 2020
Virtual meeting, from 23/11/2020 to 26/11/2020, Last updated: 27/11/2020 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 July 2020
European Medicines Agency, Amsterdam, the Netherlands, from 06/07/2020 to 09/07/2020, Last updated: 10/12/2020 -
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List of medicines under additional monitoring (updated)
Last updated: 24/02/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 September-1 October 2020
Virtual meeting, from 28/09/2020 to 01/10/2020, Last updated: 29/09/2020 -
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PDCO: Agendas, minutes and meeting reports
Last updated: 11/11/2020 -
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Paediatric Committee (PDCO): 20-23 June 2017
European Medicines Agency, London, UK, from 20/06/2017 to 23/06/2017, Last updated: 03/07/2014 -
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Medicines under evaluation
Last updated: 16/03/2020 -
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Paediatric Committee (PDCO): 16-19 May 2017
European Medicines Agency, London, UK, from 16/05/2017 to 19/05/2017, Last updated: 03/07/2014 -
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Paediatric Committee (PDCO): 10-13 October 2017
European Medicines Agency, London, UK, from 10/10/2017 to 13/10/2017, Last updated: 03/07/2014 -
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Paediatric Committee (PDCO): 12-15 December 2017
European Medicines Agency, London, UK, from 12/12/2017 to 15/12/2017, Last updated: 03/07/2014 -
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News: EMA 2017 annual report published
Last updated: 02/05/2018 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 16/02/2021 -
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Paediatric Committee (PDCO): 20-22 May 2015
European Medicines Agency, London, UK, from 20/05/2015 to 22/05/2015, Last updated: 20/05/2015 -
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Paediatric Committee (PDCO): 10-12 September 2014
European Medicines Agency, London, UK, from 10/09/2014 to 12/09/2014, Last updated: 10/12/2010 -
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Public data from Article 57 database (updated)
Last updated: 16/02/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 23-26 July 2018
European Medicines Agency, London, UK, from 23/07/2018 to 26/07/2018, Last updated: 06/01/2014