International prescription drug labeling.

P J Roylance, W A Buri
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引用次数: 0

Abstract

Yesterday's therapeutic compounds were meticulously prepared, elegantly presented, and relatively innocuous (Dunlop). Today's powerful and complex drugs are manufactured with sophisticated technology and require clear, concise, and comprehensive information for the physicians throughout the world in order to provide maximum benefit for the patient. Our company, Merck & Co, Inc, has adhered for many years to strict requirements for full and balanced disclosure in all information disseminated to professionals about our products, including circulars, labeling, and advertising. Our practice is to provide complete information to physicians, pharmacists, and regulatory authorities, both on the recommended uses for our products and on their potential adverse effects. The cornerstone of our international disclosure system, the International Physicians Circular (IPC), is provided for each product and comprises part of the initial submission to each national health authority in connection with application for marketing approval. Each IPC sets forth the company's best scientific judgment with respect to both the positive and negative aspects of our drugs, defining actions, indications, and dosage, as well as all contraindications, precautions, and side effects. These circulars are updated in the process of continuous medical review.

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国际处方药标签。
昨天的治疗化合物是精心准备的,优雅的呈现,相对无害的(邓洛普)。今天的强效和复杂的药物是用复杂的技术制造的,为了给病人提供最大的好处,世界各地的医生需要清晰、简明和全面的信息。我们公司默克公司多年来一直严格要求在向专业人士传播的关于我们产品的所有信息中充分和平衡地披露,包括通告、标签和广告。我们的做法是向医生、药剂师和监管机构提供完整的信息,包括我们产品的推荐用途和潜在的不良影响。我们的国际信息披露系统的基石是国际医师通函(IPC),该通函为每个产品提供,并构成了与上市批准申请相关的初始提交给每个国家卫生主管部门的一部分。每个IPC都阐述了公司对我们药物的积极和消极方面的最佳科学判断,定义了作用、适应症和剂量,以及所有禁忌症、预防措施和副作用。这些通告在持续的医疗审查过程中不断更新。
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来源期刊
Drug Information Journal
Drug Information Journal 医学-卫生保健
自引率
0.00%
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0
审稿时长
6-12 weeks
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