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Decitabine/cedazuridine was approved for medical use in the United States and Canada in July 2020, [7] [8] [9] [12] and in the European Union in September 2023. [6]The U.S. Food and Drug Administration (FDA) granted the application of decitabine combined with cedazuridine priority review and orphan drug designation. [7] [13] The orphan drug designation was granted in August 2019 for the ...
Medical uses. Gliclazide is used for control of hyperglycemia in gliclazide-responsive diabetes mellitus of stable, mild, non- ketosis prone, type 2 diabetes. It is used when diabetes cannot be controlled by proper dietary management and exercise and when metformin has already been tried. [11]
Safety Standards Series now includes unified Fundamental Safety Principles, which represent an international consensus on what must constitute a high level of protection and safety.
1 lip 2020 · In the EU, one of the key determinants in the regulation and management of substances to ensure adequate protection of human health is the outcome of toxicity studies. These studies should therefore be performed in a way that the data generated are adequate to fulfil all regulatory requirements.
Gliclazide. Find out how gliclazide treats type 2 diabetes and how to take it. About gliclazide. Who can and cannot take it. How and when to take it. Side effects. Pregnancy, breastfeeding and fertility. Taking gliclazide with other medicines and herbal supplements. Common questions.
Clinical trials have shown that dapagliflozin improves glycemic control without variation. It is safe and well-tolerated in the general population including older patients and those with high-risk CV factors or preexisting CV disease. There may be a renal protective role by an unknown mechanism.
14 lip 2024 · Decitabine injection is used to treat myelodysplastic syndromes (MDS), a group of cancers in which immature blood cells in the bone marrow do not mature and do not become healthy blood cells. It also treats certain types of anemia. Decitabine is an antineoplastic (cancer medicine).
