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Should all therapeutic indications be listed if the medicinal product is an anti-microbial or an anti-parasite drug?
Should all therapeutic indications be listed if the medicinal product is an anti-microbial or an anti-parasite drug?
A general description of the therapeutic indication is required (e.g. cases of serious infection combined with resistance to primary anti-microbial drugs) but some concrete examples should also be given (two or three will suffice). If a product for which marketing authorisation has been granted is available for the therapeutic indication in question, attention should be paid to detailing the indications for which the authorised product is not suitable.
10 Nov 2015