[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-177897-105":53,"doc-detail-177897-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","summary-of-product-characteristics-smpc-template-therapeutic-indications","SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) TEMPLATE - Therapeutic indications","","A WHO Summary of Product Characteristics (SmPC) template outlining how to structure core sections for medicines within the WHO Public Assessment Report framework. It provides fill-in placeholders for product identity, qualitative composition, pharmaceutical form, and clinical particulars. The included example section 4.1 defines therapeutic indications and links to related clinical subsections such as contraindications, warnings, interactions, pregnancy and lactation, and effects on driving ability. It also covers overdose, undesirable effects, and pharmacological property sections, with storage and disposal guidance placeholders.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":51,"@type":70,"position":76},"https://docshare.wps.com/template/general/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/summary-of-product-characteristics-smpc-template-therapeutic-indications/177897/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/summary-of-product-characteristics-smpc-template-therapeutic-indications/177897.png","ImageObject",442,249,{"name":88,"@type":89},"Violet","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-04","2026-09-02",true,{"@type":98,"interactionType":99,"userInteractionCount":8},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What does the SmPC template provide for section 4.1 Therapeutic indications?","Question",{"text":108,"@type":109},"It provides a placeholder structure to specify that the product is indicated for defined patient groups (e.g., adults, neonates, infants, children, adolescents, and aged groups) within the relevant indication wording.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How should posology for the paediatric population be addressed when no data exist?",{"text":113,"@type":109},"The template includes options stating that the safety and efficacy of the product in children aged specific ranges have not been established, or that currently available data are described elsewhere without a recommendation on posology.",{"name":115,"@type":106,"acceptedAnswer":116},"What guidance is included for pregnancy, lactation, and driving ability in the clinical particulars section?",{"text":117,"@type":109},"The template includes placeholders to address women of childbearing potential and contraception, plus sub-items for pregnancy, breastfeeding, and fertility. For driving ability, it provides options to state the influence level (no/negliable, minor, moderate, or major) or to indicate that no studies have been performed.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},177897,1788329563,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":50,"category_name":51,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":8,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":79,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":125,"read_time":73},4398048950312,"https://ap-avatar.wpscdn.com/avatar/400002538284de19e3c?_k=1778320343897328908","SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) TEMPLATE\n[Should the product to which a completed summary of product characteristics (SmPC) be prequalified, it will form Part 4 of the WHO Public Assessment Report that will be posted on the website of the WHO Prequalification Team: medicines (PQTm).\nPlease also consult the prequalification guidance documents: Section Guidance for Part 4  — Summary of Product Characteristics (SmPC) — of a WHO Public Assessment Report (WHOPAR) and Annotated Summary of Product Characteristics (SmPC) Template and Ensuring Consistency Between Product Information Documents.\n\u003Ctext> signifies text to be selected or deleted as appropriate.\n{text} refers to information to be added.]\n1.\tNAME OF THE MEDICINAL PRODUCT\n{(Invented) name strength pharmaceutical form}\n2.\tQUALITATIVE AND QUANTITATIVE COMPOSITION\n\u003CExcipient(s):>\nFor a full list of excipients, see Section 6.1.\n3.\tPHARMACEUTICAL form\n\u003CThe scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.>\n\u003CThe tablet can be divided into equal halves.>\n\u003CThe tablet should not be divided.>\n4.\tClinical particulars\n4.1\tTherapeutic indications\n\u003C{X} is indicated in \u003Cadults> \u003Cneonates> \u003Cinfants> \u003Cchildren> \u003Cadolescents> \u003Caged {x to y}> \u003Cyears> \u003Cmonths>>.>\nPosology and method of administration\nPosology\nPaediatric population\n\u003CThe \u003Csafety> \u003Cand> \u003Cefficacy> of {X} in children aged {x to y} \u003Cmonths> \u003Cyears> {or any other relevant subsets e.g. weight, pubertal age, gender} \u003Chas> \u003Chave> not \u003Cyet> been established.>\n\u003CNo data are available.> \u003CCurrently available data are described in Section \u003C4.8> \u003C5.1> \u003C5.2> but no recommendation on a posology can be made.>\n\u003C{X} should not be used in children aged {x to y} \u003Cyears> \u003Cmonths> {or any other relevant subsets e.g. weight, pubertal age, gender} because of \u003Csafety> \u003Cefficacy> concern(s).>\n\u003CThere is no relevant use of {X} \u003Cin the paediatric population> \u003Cin children aged {x to y} \u003Cyears>, \u003Cmonths> {or any other relevant subsets e.g. weight, pubertal age, gender} \u003Cin the indication...>\n\u003C{X} is contraindicated in children aged {x to y} \u003Cyears> \u003Cmonths> {or any other relevant subsets e.g. weight, pubertal age, gender} \u003Cin the indication...> (see Section 4.3).>\nMethod of administration\n4.3\tContraindications\n\u003CHypersensitivity to the active substance(s) or to any of the excipients \u003Cor {name of the residue(s)}>.>\n4.4\tSpecial warnings and precautions for use\n4.5\tInteraction with other medicinal products and other forms of interaction\n\u003CNo interaction studies have been performed.>\n\u003CInteraction studies have only been performed in adults.>\n4.6\tPregnancy and lactation\n[See prequalification guidance: Section Guidance for Part 4 — Summary of Product Characteristics (SmPC) — of a WHO Public Assessment Report (WHOPAR).]\n\u003CWomen of childbearing potential>\n\u003CContraception in males and females>\n\u003CPregnancy>\n\u003CBreastfeeding>\n\u003CFertility>\n4.7\tEffects on ability to drive and use machines\n\u003C{Invented name} has \u003Cno \u003Cor negligible> influence> \u003Cminor influence>, \u003Cmoderate influence> \u003Cmajor influence> on the ability to drive and use machines.>\n\u003CNo studies on the effects on the ability to drive and use machines have been performed.>\n\u003CNot relevant.>\nUndesirable effects\n[See prequalification guidance: Section Guidance for Part 4 — Summary of Product Characteristics (SmPC) — of a WHO Public Assessment Report (WHOPAR).]\n\u003CPaediatric population>\n4.9\tOverdose\n\u003CNo case of overdose has been reported.>\n5.\tPHARMACOLOGICAL PROPERTIES\n5.1 \tPharmacodynamic properties\nPharmacotherapeutic group: {group}, ATC code: {code}\n\u003CMechanism of action>\n\u003CPharmacodynamic effects>\n\u003CClinical efficacy and safety>\n\u003CPaediatric population>\n5.2\tPharmacokinetic properties\n\u003CPaediatric population>\n5.3\tPreclinical safety data\n\u003CNon-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.>\n\u003CEffects in non-clinical studies w","cbCaipgR3kLi8ZML","https://ap.wps.com/l/cbCaipgR3kLi8ZML","docx",37536,"English","# 1. Name of the medicinal product\n# 2. Qualitative and quantitative composition\n# 3. Pharmaceutical form\n# 4. Clinical particulars\n## 4.1 Therapeutic indications\n## Posology and method of administration\n## 4.3 Contraindications\n## 4.4 Special warnings and precautions for use\n## 4.5 Interaction with other medicinal products\n## 4.6 Pregnancy and lactation\n## 4.7 Effects on ability to drive and use machines\n## Undesirable effects\n## 4.9 Overdose\n# 5. Pharmacological properties\n# 6. Pharmaceutical particulars\n# 7. Applicant/Supplier\n# 8. WHO prequalification reference number\n# 9. Date of prequalification / renewal of prequalification\n# 10. Date of revision of the text","[{\"question\":\"What does the SmPC template provide for section 4.1 Therapeutic indications?\",\"answer\":\"It provides a placeholder structure to specify that the product is indicated for defined patient groups (e.g., adults, neonates, infants, children, adolescents, and aged groups) within the relevant indication wording.\"},{\"question\":\"How should posology for the paediatric population be addressed when no data exist?\",\"answer\":\"The template includes options stating that the safety and efficacy of the product in children aged specific ranges have not been established, or that currently available data are described elsewhere without a recommendation on posology.\"},{\"question\":\"What guidance is included for pregnancy, lactation, and driving ability in the clinical particulars section?\",\"answer\":\"The template includes placeholders to address women of childbearing potential and contraception, plus sub-items for pregnancy, breastfeeding, and fertility. For driving ability, it provides options to state the influence level (no/negliable, minor, moderate, or major) or to indicate that no studies have been performed.\"}]","SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) TEMPLATE - Therapeutic indications | DOCX"]