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International prescription drug labeling.

作者信息

Roylance P J, Buri W A

出版信息

Drug Inf J. 1983;17(4):239-43. doi: 10.1177/009286158301700403.

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.

摘要

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