47 new drugs approved by EU in 2014
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Last Update: 2015-01-07
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Source: Internet
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Author: User
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Source: Xinkangjie January 7, 2015 European Drug Administration approved 47 new active substance drugs in 2014 Among them, 9 are new drugs for respiratory diseases, 9 for infectious diseases, 7 for tumors, 5 for endocrine diseases, 3 for cardiovascular diseases, 3 for digestive system diseases, 2 for nervous system diseases, 2 for eye diseases, 2 for genetic diseases and 5 for other diseases Figure 1 data source of drug disease classification of new active substances approved by EMEA in 2014: the European Medicines Agency (EMEA) is a branch of the European Union, which is responsible for mobilizing technical forces of Member States to evaluate, supervise and inspect drugs EMEA provides scientific advice to Member States and EU research institutions on the evaluation of safety, effectiveness and quality controllability of human drugs or veterinary drugs in accordance with relevant pharmaceutical management laws and regulations Human drugs approved by EMEA include new active substance, generics and biosimilars New active substance is defined as a new chemical, biological or radioactive pharmaceutical active substance, which includes: 1) drugs, radioactive drugs, biological products and plant products that have never been listed in Europe; 2 )There are obvious similarities and differences between the safety and effectiveness of the isomers of the approved drugs, or the mixtures, compounds, derivatives of the isomers, or the salt chemicals of the approved drugs and the "parent" chemicals of the approved drugs; 3 )A biological product substance has been approved as a pharmaceutical product by the European Union, but when its molecular structure, the characteristics of the source substance or the manufacturing process change significantly, the changed biological product belongs to the new active substance; 4 )A radiopharmaceutical substance of a radionuclide or ligand that has not been approved as a drug by the European Union in the past, or the coupling method of a linker and a radionuclide has not been approved by the European Union In 2014, the European Drug Administration approved 47 new active substances, including 9 new drugs for asthma / chronic obstructive pulmonary disease, 5 new drugs for diabetes, 4 new drugs for chronic hepatitis C, 3 new drugs for multidrug-resistant tuberculosis, 3 new drugs for leukemia, 2 new drugs for AIDS, 2 new drugs for multiple sclerosis and 2 new drugs for glaucoma Unresectable malignant melanoma, giant lymphadenopathy, infantile hemangioma, metastatic medullary thyroid cancer, acute coronary syndrome, myocardial infarction, chronic thromboembolic pulmonary hypertension, hyperphosphatemia in dialysis patients with chronic nephropathy, Duchenne's progressive muscular dystrophy, transplant rejection, moderate to severe Crohn's disease and ulcerative colitis, IVA One drug for mucopolysaccharide type A, one for painkiller, one for congenital bile acid synthesis disorder, one for schizophrenia, one for rosacea induced facial erythema, one for β - amyloid protein contrast agent of Alzheimer's disease and one for opiate induced constipation Data source of new active substances approved by EMEA in 2014: website of European Drug Administration (EMEA)
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