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Keyword Steglatro Remove keyword
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Summary of opinion: Steglatro
ertugliflozin, opinion date: 16/09/2021, Positive, Last updated: 30/09/2021Steglatro: Pending EC decision … opinion2 (post authorisation) Steglatro ertugliflozin On 16 September … for the medicinal product Steglatro. The marketing authorisation … -
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Opinion/decision on a Paediatric investigation plan (PIP): Steglatro, Ertugliflozin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001533-PIP01-13-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 17/04/2019, Last updated: 24/06/2019, Compliance check: XInvented name Steglatro Active substance Ertugliflozin … Steglatro Steglatro ertugliflozin Ertugliflozin ertugliflozin … -
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Human medicine European public assessment report (EPAR): Steglatro
ertugliflozin l-pyroglutamic acid, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2018,
, Revision: 7, Authorised, Last updated: 16/02/2022
Steglatro Nutritional and Metabolic … Steglatro … EMA/533007/2021EMEA/H/C/004315 Steglatro (ertugliflozin) An overview … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2018
CHMP, Last updated: 26/01/2018Steglatro … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021
CHMP, Last updated: 17/09/2021Steglatro … -
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Human medicine European public assessment report (EPAR): Segluromet
ertugliflozin l-pyroglutamic acid, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 23/03/2018,, Revision: 5, Authorised, Last updated: 16/02/2022
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Human medicine European public assessment report (EPAR): Steglujan
ertugliflozin l-pyroglutamic acid, sitagliptin phosphate monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 23/03/2018,, Revision: 8, Authorised, Last updated: 26/11/2021
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Committee for Medicinal Products for Human Use (CHMP): 22-25 February 2021
European Medicines Agency, Amsterdam, the Netherlands, from 22/02/2021 to 25/02/2021, Last updated: 07/12/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 June 2021
European Medicines Agency, Amsterdam, the Netherlands, from 21/06/2021 to 24/06/2021, Last updated: 07/12/2021 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 17/06/2022 -
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List of medicines under additional monitoring
Last updated: 25/05/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 February 2021
European Medicines Agency, Amsterdam, the Netherlands, from 08/02/2021 to 11/02/2021, Last updated: 08/02/2021 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 22/06/2022 -
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Download medicine data
Last updated: 02/12/2021 -
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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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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 March 2021
European Medicines Agency, Amsterdam, the Netherlands, from 08/03/2021 to 11/03/2021, Last updated: 27/02/2018 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021
PRAC, Last updated: 12/02/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 7-10 December 2020
Virtual meeting, from 07/12/2020 to 10/12/2020, Last updated: 04/11/2019 -
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Committee for Medicinal Products for Human Use (CHMP): 13-16 September 2021
European Medicines Agency, Amsterdam, the Netherlands, from 13/09/2021 to 16/09/2021, Last updated: 04/11/2019 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/03/2022 to 10/03/2022, Last updated: 21/06/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 March 2021
PRAC, Last updated: 12/03/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022
PRAC, Last updated: 11/03/2022 -
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Annual reports and work programmes (updated)
Last updated: 10/06/2022 -
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European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP) and Healthcare Professionals' Organisations (HCPWP) joint meeting
European Medicines Agency, London, UK, from 17/04/2018 to 18/04/2018, Last updated: 27/06/2018 -
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Newsletters
Last updated: 15/02/2022