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For fixed galenical formulations of combination products developed for the H. pylori eradication therapy, the CPMP guideline for fixed combination products will be applicable. The requirements for specific information on individual components of the combination and the claimed dose regimen should be addressed appropriately, depending on the extent of knowledge of efficacy and safety of some components of the regimen. Although, this category of products is not within the scope of this Points to consider document the points and criteria mentioned here for the SPC will be applicable also for such products. The information on antibacterial activity in the Pharmacodynamic section ; should focus on susceptibility of H. pylori to the involved agents. In principle, the appropriate dose to be used in an indication for combination therapy should be mentioned in the individual product information of each component of the combination therapy. For H. pylori associated conditions such as gastritis with serious abnormalities, post early gastric cancer resection, mucosa-associated lymphoid tissue MALT ; lymphoma MALToma ; 1 adequate evidence of efficacy and safety in such clinical conditions and for each proposed combination regimen must be evaluated in appropriate state of the art and regulatory settings. These are not within the scope of this document. However, similar SPC formatting as for management of H. pylori associated ulcer disease may be used. In that case instead of ulcer disease the specific clinical condition is mentioned and the appropriate and adequately evaluated ; combination dosing regimens and corresponding success rates are mentioned. For single-entity medicinal products the format for each category of the involved medicinal products is as follows. 1. Ulcer healing Agents UHA and hydrodiuril. Table 1. Demographics and Baseline Characteristics, for instance, ibuprofen. The dose should be carefully checked in case of children, and for all categories of potent dangerous drugs. Confirm the units written on the prescription, i.e. milligrams, micrograms, decimal points, etc and oretic.

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