欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Tamiflu
适用类别Human
治疗领域Influenza, Human
通用名/非专利名称oseltamivir
活性成分oseltamivir
产品号EMEA/H/C/000402
患者安全信息No
许可状态Authorised
ATC编码J05AH02
是否额外监管No
是否仿制药或hybrid药物No
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2002/06/20
上市许可开发者/申请人/持有人Roche Registration GmbH
人用药物治疗学分组Antivirals for systemic use
兽用药物治疗学分组
审评意见日期2002/03/21
欧盟委员会决定日期2025/04/15
修订号43
治疗适应症Treatment of influenza Tamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.Prevention of influenza Post-exposure prevention in individuals one year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. The appropriate use of Tamiflu for prevention of influenza should be determined on a case-by-case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older. Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic-influenza outbreak. Tamiflu is not a substitute for influenza vaccination. The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations.
适用物种
兽用药物ATC编码
首次发布日期2018/08/09
最后更新日期2025/04/15
产品说明书https://www.ema.europa.eu/en/documents/product-information/tamiflu-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/tamiflu
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