Abstract: . . .  Sedation, antibody formation and immunsuppression effects must be addressed, depending on the mechanism of action. Separate safety data are needed for SAR/PAR given the difference in long-term use. See also IV.3 For topical products, provided significant systemic exposure is excluded, local safety is more relevant. IV.2 Extent of population Safety profiles must be acceptable among adult and elderly patients. The overall patient database should include a suitable number of patients as per ICH guideline. IV.3 Long term safety Data should include an appropriate number of patients evaluated for 6 months and a suitable number of patients evaluated for one year as per ICH guideline. For topical products, provided significant systemic exposure is excluded long term local safety is more relevant.  . . .
. . .  of age the immune response is considered different. Therefore below this age separate clinical studies for efficacy are needed assuming that the correct population can be defined. Safety data are of paramount importance and 1- 3 months of paediatric safety data are required. Further, special care has to be taken to avoid the side effects including growth effects typical in this age group. Referred is to ICH11 NfG on Clinical Investigation of Medicinal Products in the Paediatric Population. IV. CLINICAL SAFETY EVALUATION IV.1 Adverse events Trials should address safety monitoring i.e. adverse events, routine laboratory haematology, biochemical tests and urinalysis. For some allergic rhino- conjunctivitis drugs a more thorough cardiac safety evaluation may be indicated particularly if a QT problem is suspected. Page 9 EMEA/CHMP/EWP/2455/02 Page 9/9 EMEA 2004 Important safety issues for intranasal corticosteroids include assessment of adrenal function. Sedation, antibody formation and immunsuppression effects must be addressed, depending on the mechanism of action. Separate safety data are needed for SAR/PAR given the difference in long-term use. See also IV.3 For topical products, provided significant systemic exposure is excluded, local safety is more relevant. IV.2 Extent of population Safety profiles . . .
--3000,2,750,2550,26235