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Press release: European Medicines Agency recommends authorisation of novel treatment for type-2 diabetes
CHMP, Last updated: 20/04/2012authorisation of novel treatment for type-2 diabetes … control in adult patients with type-2 diabetes mellitus … authorisation of novel treatment for type 2 diabetes 7 Westferry Circus … -
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Press release: New treatment for children with type 2 diabetes
Last updated: 28/06/2019treatment for children with type 2 diabetes … aged 10 years or older with type 2 diabetes. This medicine is already … and exercise in adults with type 2 diabetes, on its own or as an add-on … -
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Press release: First oral GLP-1 treatment for type 2 diabetes
CHMP, Last updated: 31/01/2020oral GLP-1 treatment for type 2 diabetes … insufficiently controlled type 2 diabetes to improve glycaemic control … medicines for people with type 2 diabetes - developed for oral use … -
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Press release: New add-on treatment to insulin for treatment of certain patients with type 1 diabetes
CHMP, Last updated: 01/03/2019of certain patients with type 1 diabetes … for certain patients with type 1 diabetes mellitus. Zynquista is a … inhibitor for the treatment of type 1 diabetes to be recommended for authorisation … -
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Press release: First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes
CHMP, Last updated: 01/02/2019of certain patients with type 1 diabetes … for certain patients with type 1 diabetes mellitus. Dapagliflozin is … treatment of patients with type 2 diabetes. It belongs to a new generation … -
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Press release: Investigation into GLP-1-based diabetes therapies concluded
CHMP, Last updated: 26/07/2013vestigation into GLP-1-based diabetes therapies concluded … finalised a review of GLP-1-based diabetes therapies. The Committee … these medicines. The rise of type-2 diabetes is a major public-health … -
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News: European Medicines Agency finalises update to diabetes guideline
CHMP, Last updated: 29/06/2012Agency finalises update to diabetes guideline … treatment or prevention of diabetes mellitus , published today … for treating or preventing diabetes. The main change to the guideline … -
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Press release: First medicine to treat neonatal diabetes
CHMP, Last updated: 23/02/2018medicine to treat neonatal diabetes … the treatment of neonatal diabetes mellitus (NDM), for use in … infants and children. Neonatal diabetes is an extremely rare form of diabetes that is diagnosed in the … -
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Press release: EMA update on metformin diabetes medicines
Last updated: 06/12/2019EMA update on metformin diabetes medicines … small number of metformin diabetes medicines outside the EU … from not having adequate diabetes treatment far outweighs possible … -
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News: Facilitating global access to diabetes treatments for non-EU patients
CHMP, Last updated: 22/04/2022Facilitating global access to diabetes treatments for non-EU patient … a recommendation for two diabetes mellitus treatments, Actrapid … regulatory resources. The two diabetes medicines were submitted … -
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Press release: EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes
CHMP, Last updated: 26/02/2016with SGLT2 inhibitors for diabetes … 1 to minimise the risk of diabetic ketoacidosis in patients … SGLT2 inhibitors (a class of type 2 diabetes medicines Diabetic ketoacidosis is a serious … -
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Press release: Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function
Last updated: 14/10/2016Use of metformin to treat diabetes now expanded to patients … ml/min) for the treatment of type 2 diabetes. The product information for … Use of metformin to treat diabetes now expanded to patients … -
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Press release: SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis
PRAC, Last updated: 12/02/2016recommendations to minimise risk of diabetic ketoacidosis … SGLT2 inhibitors (a class of type 2 diabetes medicines) and has made recommendations … recommendations to minimise the risk of diabetic ketoacidosis Diabetic ketoacidosis is a serious … -
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News: World Diabetes Day – more treatment options to meet needs of growing patient numbers
CHMP, Last updated: 14/11/2013World Diabetes Day – more treatment options … News 14/11/2013 World Diabetes Day - Take a step for diabetes Additional treatment options … Additional treatment options for type-2 diabetes are critically needed. The … -
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Press release: Cerdelga recommended for approval in type 1 Gaucher disease
CHMP, Last updated: 21/11/2014recommended for approval in type 1 Gaucher disease … recommended for approval in type 1 Gaucher disease … recommended for approval in type 1 Gaucher disease New … -
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News: First treatment for rare condition primary hyperoxaluria type 1
CHMP, Last updated: 16/10/2020condition primary hyperoxaluria type 1 … condition primary hyperoxaluria type 1 … -
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News: New medicine for rare type of eye cancer
CHMP, Last updated: 25/02/2022New medicine for rare type of eye cancer … with uveal melanoma, a rare type of eye cancer. Uveal melanoma … substance of Kimmtrak, is a type of treatment called a bispecific … -
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News: Public consultation opens on standard paediatric investigation plans for two types of cancer in children
PDCO, Last updated: 22/02/2013investigation plans for two types of cancer in children … plans (PIPs) for two specific types of cancer with unmet medical … needs of these two particular types of cancer, set out the principal … -
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News: Procedural update on submission of Type I variations to EMA in March, April and May 2019
Last updated: 26/02/2019ural update on submission of Type I variations to EMA in March … to submit Brexit-related Type IA and Type IB variations in March 2019 … requirements before this date. Type I variations are minor changes … -
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News: Regulatory update - EMA encourages companies to submit type I variations for 2018 by end of November 2018
Last updated: 26/10/2018encourages companies to submit type I variations for 2018 by … authorisation holders to submit type IA IN and type IA variations for 2018 no … to report Brexit-related Type IA/IA IN variations in December … -
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News: Regulatory update - EMA encourages companies to submit type I variations for 2020 by end of November
Last updated: 29/10/2020encourages companies to submit type I variations for 2020 by … encourages companies to submit type I variations for 2020 by … -
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News: Regulatory update - EMA encourages companies to submit type I variations for 2021 in November 2021
Last updated: 29/10/2021encourages companies to submit type I variations for 2021 in … encourages companies to submit type I variations for 2021 in … -
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News: First therapy to treat two types of Niemann-Pick disease, a rare genetic metabolic disorder
CHMP, Last updated: 20/05/2022First therapy to treat two types of Niemann-Pick disease … First therapy to treat two types of Niemann-Pick disease … -
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Press release: European Medicines Agency recommends approval of first higher-strength insulin for treatment of patients with diabetes mellitus in the EU
CHMP, Last updated: 19/10/2012treatment of patients with diabetes mellitus in the EU … insulin for the treatment of diabetes mellitus in adults. It is … between 200,000 and 700,000 diabetes patients in the EU require … -
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Press release: New recommendations to minimise risks of the rare brain infection PML and a type of skin cancer with Gilenya
CHMP, Last updated: 18/12/2015brain infection PML and a type of skin cancer with Gilenya … carcinoma is a slow-growing type of skin cancer which almost … diseases, including PML and some types of cancer. So far 3 confirmed …