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1991年3月12日欧洲共同体的 CPMP对杨森制药公司的氟桂嗪采取了一个药学上比较警惕的意见,意见认为原则上该产品只有两种适应证是可以接受的,即顽固性偏头痛的预防和前庭功能性眩晕,其它适应证都应该撤销。意见对于氟桂嗪两种可接受的适应证的全文是:①预防经常发作的、其它治疗无满意结果或导致严重不良反应的严再性偏头痛;②由于已确诊的前庭系统功能障碍而引起的前庭性眩晕的对症治疗。CPMP 还要求杨森做如下工作:(1)制定对氟桂嗪进行密切监视的计划,以估计其不良反应的发生率、发生频度及易感人群;
The CPMP of the European Community on March 12, 1991, took a pharmacologically vigilant view of Janssen’s flunarizine. The opinion was that in principle there were only two indications of the product that were acceptable, namely refractory migraine Prevention and vestibular functional dizziness, other indications should be withdrawn. Opinion The two accepted indications for flunarizine are: (1) the prevention of recurrent migraines, often recurrent, and other treatments that are unsatisfactory or cause serious adverse reactions; (2) dysfunction of the vestibular system that has been diagnosed Symptomatic treatment of vestibular vertigo. The CPMP also requires Janssen to do the following: (1) Develop a plan for close surveillance of flunarizine to estimate the frequency of adverse reactions, frequency of occurrence, and susceptible populations;