Rosuvastatin calcium Drug Report

Rosuvastatin calcium was jointly developed by Shionogi and AZ It was first approved for listing in the Netherlands on November 6, 2002, and then approved for listing by the US Food and Drug Administration (FDA) on August 12, 2003 It was approved for listing by PMDA of Japan on January 19, 2005 It was listed and sold by AstraZeneca in the Netherlands under the trade name of CR Estor Catalogue 1 > summary information 2 > drug overview 3 > API information 4 > pharmacological action 5 > Listing in the United States (19 articles) 6 > Listing in the European Union (191 articles) 7 > Listing in Japan (5 articles) 8 > major listing countries / regions (43 articles) 9 > Listing in China (34 articles) 10 > registration and declaration in China (262 articles) 11 > drug standards (2 articles) 12 > drug instructions (33 articles) 13 > global clinical trials (25 articles) 14> US patent status (11 articles) 15 > more details 1 > abstract information 2 > drug overview Rosuvastatin is a competitive HMG CoA reductase inhibitor, which has similar mechanism with other statins: (1) as an assistant treatment of diet control, it is used to reduce the total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C), apoB and triglyceride (TG) levels in patients with primary hyperlipidemia and mixed dyslipidemia To raise the level of HDL-C and total cholesterol; (2) to treat hypertriglyceridemia as an auxiliary means outside diet control; (3) to treat primary β - lipoproteinemia as an auxiliary means outside diet control; (4) to reduce LDL-C, TC and apoB in homozygous familial hypercholesterolemia (hofh); (5) ）As part of the treatment strategy of reducing TC and LDL-C in addition to diet control, it can slow down the progression of atherosclerotic patients; (6) for 10 to 17-year-old patients with heterozygous familial hypercholesterolemia (hefh), the decrease of LDL-C, TC and apoB after the failure of diet treatment in full trial; (7) the reduction of patients with coronary heart disease has no obvious clinical symptoms, but there are Multiple risk factors for myocardial infarction, stroke, and risk of cerebrovascular revascularization Crestor is an oral tablet containing 5mg, 10mg, 20mg or 40mg rosuvastatin The recommended dose is 5-40mg per time, once a day, either with meal or on an empty stomach 40mg dose is only used for patients who do not reach the expected goal of LDL-C after 20mg dose is used 3> API information structure formula: Chemical Name: 6-heptenoicacid, 7 - [4 - [4-fluorphenyl] - 6 - [1-methyletyl] - 2 - [methylsulfonyl] amino] - 5-pyrimidinyl] - 3,5-dihydroxy -, calciumsalt [2:1], [3R, 5S, 6e] - CAS Registration No.: 287714-14-4 molecular formula: 2c22h27fn3o6s · CA 4 > pharmacological action ATC classification: c10aa07 cardiovascular system > lipid regulator > lipid regulator, single prescription > β - hydroxy - β - methylglutaryl coenzyme A reductase inhibition drug target: hydraxymethylglutaryl coardeuctase (HMG coardeuctase) 5 > US listing (19 articles) 6 > EU listing (191 articles) Note: due to the large amount of data, only 20 pieces of data are listed here Please go to the PDF full text of the final report 7> Listing in Japan (5 articles) 8 > major listing countries / regions (43 articles) 9 > Listing in China (34 articles) Note: due to the large data space, only the data of medical insurance are listed here, please go to the PDF full text of the end report 10> China's registration application (article 262): due to the large amount of data, only data approved since 2016 are listed here Please go to the PDF full text of the final report 11> Note: due to the large amount of data, only domestic data are listed here Please go to the PDF full text of the final report 13> Global clinical trials (25 items) Note: due to the large amount of data, only phase 3 and phase 4 clinical data in the recruitment status from 2010 to now are listed here Please go to the PDF full text of the final report 14> US patent status (11) 15 > more details rosuvastatin calcium drug report.pdf