Europe drug labeling

The intent of this chapter is to review drug labels in North America, Europe and Japan. The philosophy of these differing types of labeling will be explored. The reader can easily access local examples of current, approved labeling these will not be reproduced here, and could, in any case, become rapidly out of date. Much of the content of drug labeling is the subject of other... 

As can be seen, the structure of a Japanese drug label is a standard format that would also be familiar to physicians in Europe or North America. 

A further aspect that may add to the development work relates to the method of administration. In addition to the standards methods of administration associated with human medicines, veterinary medicines may be introduced to animals through medicated feeds. Such practices have been most commonly associated with the use of antibiotics or other substances to enhance animal performance under intensive farming systems. The use of medicated feeds has been phased out in Europe since the end of 2005, with the exception of coccidiostats and histomonostats intended to kill or inhibit protozoa. In the U SA, however, medicated feeds are still commonplace. Thus, the developer may have to consider the stability and appropriate labelling of the drug when compounded into medicated feeds. 

Fischer D, Kissel T (2001) Histochemical characterization of primary capillary endothehal cells from porcine brains using monoclonal antibodies and fluorescein isothiocyanate-labelled lectins Implications for drug delivery. Europ J Pharm Biopharm 52 1-11... 

Many drugs have not been approved for use in horses. Products approved for equine use are marked with an asterisk (US) or dagger (Europe). An equine approved product and the label dose should be used whenever possible. It is strongly recommended that the manufacturers instructions and scientific literature be investigated thoroughly before a drug is used. Drug interactions must be taken into account and adverse reactions can occur. ... 

There is no evidence that BST poses a health threat to humans or animals. It has been studied more than any other animal drug, and has been found safe by FDA and many other scientific bodies in the U.S., Europe, and around the world. FDA also concludes there is no legal basis requiring the labeling of BST milk, since the milk is indistinguishable from non-BST milk. 

This mechanism should pertain to individuals otherwise at risk of thrombosis, such as those with rheumatoid arthritis, as the relative risk of myocardial infarction is increased in these patients compared to patients with osteoarthritis or no arthritis. The incidence of myocardial infarction and stroke has diverged in such at-risk patients when COX-2 inhibitors are compared with tNSAIDs. Placebo-controlled trials have now revealed an increased incidence of myocardial infarction and stroke in patients treated with rofecoxib, valdecoxib, and celecoxib, consistent with a mechanism-based cardiovascular hazard for the class. Regulatory agencies in the U.S., Europe, and Australia have concluded that all three drugs increase the risk of heart attack and stroke and will be labeled accordingly and restricted with respect to marketing directly to consumers. Only celecoxib remains on the market in the U.S. 

A very important cultural difference between Europe and the USA, that impacts upon drug development, is indirectly expressed at the stage when the regulatory authority examines the final submitted dossier. In the USA, the FDA adopts a bottom-up stance, in which it looks at the basic raw data and sees what conclusions can be drawn from it, using its own criteria for analysis and interpretation. In Europe the authorities adopt an attitude diametrically opposed to that of the FDA, by looking at the conclusions of all the studies, as manifested in the proposed labelling, patient leaflets, and summary of product information, and examining to what extent the data presented justify these conclusions. In Europe, considerable importance is placed on the role of independent experts, whose critical reports on the various sections of the dossier provide a sort... 

---