The GCC Guidance for Presenting the SPC, PIL and Labeling ...

− In case of tablets designed with a score line, information should be given whether or notreproducible dividing of the tablets has been shown. e.g.:.4. Clinical particulars4.1 Therapeutic indications− The indication(s) should be stated clearly and concisely and should define the targetdisease or condition distinguishing between treatment (symptomatic, curative ormodifying the evolution or progression of the disease), prevention (primary orsecondary) and diagnostic indication. When appropriate it should define the targetpopulation especially when restrictions to the patient populations apply.− When the product is indicated in a specific age group such as children/adolescents, theindication should state the age limit e.g. ‘X is indicated in from the age of X ‘.4.2 Posology and method of administration− In case of restricted medical prescription start this section by specifying the conditions.− The route of administration and concise relevant instruction for correct administrationand use should be given here.− Instructions for preparation are to be placed under section 6.6 or 12, and crossreferencedhere.− Dose recommendations (e.g. mg, mg/kg, mg/m 2 ) should be specified per dose interval foreach category where appropriate (specify age/weight/body surface area of subsets of thepopulation as appropriate). Frequency of dosing should be expressed using time units(e.g. once or twice daily or every 6 hour) and, to avoid confusion, abbreviations e.g. ODor BID should not be used.Page 20 of 52