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

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Patient Information Leaflet (PIL){(Invented) name strength pharmaceutical form}{Active substance(s)}The (invented) name of the medicinal product (referred to as X throughout this document)followed by the strength and pharmaceutical form (i.e. as it appears in the SPC) should bestated here in bold. This should be followed by the active substance(s) (as stated on thelabel section 1), which may be written on the line below.In this leaflet:1. What {product name}is and what it is used for2. Before you {product name}3. How to {product name}4. Possible side effects5. How to store {product name}6. Further informationPage 12 of 52
1. What {product name} is and what it is used for− Pharmacotherapeutic group:The pharmacotherapeutic group or type of activity should be stated here using patientunderstandable language.− Therapeutic indications:The therapeutic indications should be stated here, using patient understandablelanguage. If appropriate, specify that:2. Before you {product name}a. Do not {product name}− − b. Take special care with {product name}− − − c. other medicines, herbal or dietary supplements− Describe the effects of other products on {product name} and vice versa.Page 13 of 52
Page 1 and 2: Executive Board of the Health Minis
Page 3 and 4: ContentsI. Introduction 4II. Labeli
Page 5 and 6: II. LabelingThe data should be pres
Page 7 and 8: j. Special precautions for disposal
Page 9 and 10: 3. Minimum particulars to appear on
Page 11: III. Patient Information Leaflet (P
Page 15 and 16: 3. How to {product name} − You
Page 18 and 19: d. This leaflet was last approved i
Page 20 and 21: − In case of tablets designed wit
Page 22 and 23: − In the overall assessment, all
Page 24 and 25: these are not available, results ob
Page 26 and 27: 6. Pharmaceutical particulars6.1 Li
Page 28 and 29: 6.6 Special precautions for disposa
Page 30 and 31: Appendix 1: Recommended labeling st
Page 32 and 33: Appendix 3: Pregnancy statements1.-
Page 34 and 35: 8.- Well-conducted epidemiological
Page 37 and 38: Appendix 5: Additional information
Page 39 and 40: ماهوإسم المستحضر <
Page 41 and 42: ملاحظة:‏يجب أن تكو
Page 43 and 44: A. Recommendations for the PILGener
Page 45 and 46: 4. Print colorAccessibility is not
Page 47 and 48: 8. Use of symbols and pictogramsThe
Page 49 and 50: 2. Strength and total contentIn som
Page 51 and 52: Small containersWhere the labeling

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