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arznei-telegramm 2013; 44: 38-9

 


Guideline against misleading and trivialising trade names: The trade names of medicines are used to differentiate and distinguish preparations from each other. Often, however, they also serve to promote the marketing of these products. For more than five years, the European Medicines Agency, EMA, has been trying to tackle the worst practice in the naming of centrally authorised medicines by means of a guideline (EMA: Guideline on the acceptability of names for human medicinal products processed through the centralised procedure, 11 December 2007). The German regulatory authorities, BfArM and PEI, also now provide detailed guidance in order to prohibit future trade names, which could result in confusion and in the incorrect use of products due to their names being unclear, misleading and trivialising (BfArM and PEI Guideline on the naming of medicines, March 2013). The guidelines do not, however, help against already established negative practices with respect to naming. There is also no indication that manufactures are, on their own initiative, resigning from the use of profitable, but misleading trade names. Thus, the antihistamine preparation SUPERPEP (dimenhydrinate), which is offered as a remedy for travel sickness, is neither "super" nor pepping up, but instead is a medicine of questionable benefit, which can affect the capacity of reaction (arznei-telegramm's Medicines Database [atd]: Evaluation of Dimenhydrinate, as of 21 December 2012). Correctly matching an active substance with trade names is made difficult by so-called brand "stretching" by means of umbrella brands, through which the trust in preparations with established trade names is extended to other products from the same manufacturer. Thus preparations with different active substances conceal themselves behind umbrella brands such as JACUTIN PEDICUL and WICK DAYMED (see a-t 2006; 37: 14). This also applies to FENISTIL, which for decades has been synonymous with the antihistamine dimethindene maleate used in the treatment of allergy. For some time, however, FENISTIL HYDROCORT cream has been available, which contains hydrocortisone exclusively, and not as an added ingredient as suggested by the name, as well as medical devices containing no active substances (FENISTIL wound healing gel, FENISTIL cooling roll-on). Arguments have been continuing for years between BfArM and Novartis concerning the name FENISTIL PENCIVIR, which contains only the virostatic penciclovir and is used as an external treatment for oral herpes. In the first instance, the Cologne Administrative Court upheld the right of the authority to reject this name, because the main brand name overrides the suffix (see a-t 2011; 42: 55-6). Since 2011, however, an appeal initiated by the supplier, Novartis, has been pending. Some companies obviously attach more importance to popular umbrella brands than to trade names, which avoid confusion. Only generic naming, namely statement of active substance plus manufacturer, would significantly contribute to transparency and to the safety of medicines, - Ed.



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