204 results
Keyword Gliben Remove keyword
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Orphan designation: glibenclamide for: Treatment of neonatal diabetes
Date of designation: 15/01/2016, Positive, Last updated: 04/01/2019glibenclamide … opinion on orphan designation Glibenclamide for the treatment of neonatal … opinion on orphan designation Glibenclamide for the treatment of neonatal … -
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Human medicine European public assessment report (EPAR): Amglidia
glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018,
, Revision: 5, Authorised, Last updated: 16/02/2023
glibenclamide … expected to prescribe Amglidia (glibenclamide oral suspension) will be … active substance in Amglidia, glibenclamide, is a diabetes medicine that … -
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Opinion/decision on a Paediatric investigation plan (PIP): glibenclamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001324-PIP01-12-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension
Decision date: 01/04/2015, Last updated: 06/05/2015, Compliance check: XKey facts glibenclamide OtherP/0072/2015EMEA-001324-PIP01-12-M01 … paediatric investigation plan for glibenclamide (EMEA-001324-PIP01-12-M01 … paediatric investigation plan for glibenclamide (EMEA-001324-PIP01-12-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): glibenclamide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002651-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 29/01/2020, Last updated: 10/06/2020, Compliance check: XKey facts glibenclamide NeurologyP/0043/2020EMEA-002651-PIP01-19 … product specific waiver for glibenclamide (EMEA-002651-PIP01-19) PDF … glibenclamide … -
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Press release: First medicine to treat neonatal diabetes
CHMP, Last updated: 23/02/2018Amglidia is a new formulation of glibenclamide, specifically developed for … Union (EU) for Amglidia (glibenclamide), a medicine indicated for … a new oral formulation of glibenclamide, a medicine which is already … -
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Human medicine European public assessment report (EPAR): Prandin
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 29/01/2001, Revision: 16, Authorised, Last updated: 14/05/2018used in type-2 diabetes (glibenclamide, glipizide or gliclazide … used in type 2 diabetes (glibenclamide, glipizide or gliclazide … -
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Human medicine European public assessment report (EPAR): NovoNorm
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 16/08/1998, Revision: 16, Authorised, Last updated: 28/09/2017used in type 2 diabetes (glibenclamide, glipizide or gliclazide … used in type 2 diabetes (glibenclamide, glipizide or gliclazide … -
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Press release: European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection
Last updated: 19/11/2013flunitrazepam, ganciclovir, glibenclamide, granisetron, interferon alfa-2a … flunitrazepam, ganciclovir, glibenclamide, granisetron, interferon alfa-2a … -
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National expert: Gabriele Maurer, Paul Ehrlich Institute (updated)
- Declaration of interests - 80.98 KB | PDF
- Curriculum Vitae - 16.52 KB | PDF
Biogen Idec Research Limited glibenclamide severe cerebral edema following … -
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Press release: Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function
Last updated: 14/10/2016addition, the combination glibenclamide/metformin (Glucovance) has been nationally … -
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National expert: Ulrich Russ, Federal Institute For Drugs And Medical Devices (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 21.94 KB | PDF
ventricular myocytes. Effects of glibenclamide. Pflugers Arch. - Eur. J … vascular sulfonylurea receptor SUR2B for glibenclamide. Mol. Pharmacol. (1999) 56 … K+ channels: Comparison with glibenclamide J. Pharmacol. Exp. Ther … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2018
CHMP, Last updated: 23/02/2018glibenclamide), for the treatment of neonatal … -
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National expert: Robert Porszasz, National Institute of Pharmacy and Nutrition (updated)
- Declaration of interests - 80.17 KB | PDF
- Curriculum Vitae - 30.77 KB | PDF
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National expert: Juha Vakkilainen, Finnish Medicines Agency (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 19.37 KB | PDF
Effects of nateglinide and glibenclamide on postprandial lipid and … -
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National expert: Marika Ruponen, Finnish Medicines Agency (updated)
- Declaration of interests - 80.24 KB | PDF
- Curriculum Vitae - 32.18 KB | PDF
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Human medicine European public assessment report (EPAR): Stayveer
bosentan (as monohydrate), Hypertension, Pulmonary; Scleroderma, Systemic
Date of authorisation: 24/06/2013, Revision: 15, Authorised, Last updated: 13/02/2023 -
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Human medicine European public assessment report (EPAR): Ebymect (updated)
dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2015, Revision: 18, Authorised, Last updated: 06/03/2023 -
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Human medicine European public assessment report (EPAR): Tracleer
bosentan (as monohydrate), Scleroderma, Systemic; Hypertension, Pulmonary
Date of authorisation: 14/05/2002, Revision: 42, Authorised, Last updated: 13/02/2023 -
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Human medicine European public assessment report (EPAR): Zomarist (updated)
vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 30/11/2008, Revision: 23, Authorised, Last updated: 20/03/2023 -
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Human medicine European public assessment report (EPAR): Velmetia
sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/07/2008, Revision: 35, Authorised, Last updated: 20/02/2023 -
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Human medicine European public assessment report (EPAR): Xigduo (updated)
metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 16/01/2014, Revision: 19, Authorised, Last updated: 06/03/2023 -
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Human medicine European public assessment report (EPAR): Vokanamet (updated)
canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 23/04/2014, Revision: 20, Authorised, Last updated: 27/02/2023 -
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Human medicine European public assessment report (EPAR): Erivedge (updated)
vismodegib, Carcinoma, Basal Cell
Date of authorisation: 12/07/2013,
Date of refusal: 26/04/2013, Revision: 15, Authorised, Last updated: 20/03/2023 -
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Human medicine European public assessment report (EPAR): Efficib
sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/07/2008, Revision: 32, Authorised, Last updated: 31/01/2023 -
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Human medicine European public assessment report (EPAR): Onglyza
Saxagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 30/09/2009, Revision: 21, Authorised, Last updated: 15/12/2022