Example Reported LLT Selected Comment Unclear if the purpose is to induce weight loss Weight loss Weight loss or to treat an underweight patient Unclear if the purpose Immunosuppression Immunosuppression is to induce or to treat immunosuppression 3.26.2 Complex indications Term selection for some indications (e.g., in regulated product information) may be complex and require selection of more than one LLT to represent the information completely, depending on the circumstances. Example Reported LLT Selected Comment Treatment of Aggression aggression in autism The products do not treat the underlying Treatment of Chronic iron chronic iron autism, thalassemia, or myocardial overload infarction, but they do address the overload in associated signs/symptoms (aggression, thalassemia major chronic iron overload, atherothrombosis). It may be necessary to select LLT Autism, LLT Thalassemia major, or LLT Prevention of Myocardial infarction based on regional atherothrombotic prophylaxis regulatory requirements. events in patients with myocardial infarction 3.26.3 Indications with genetic markers or abnormalities For indications that describe a genetic marker or abnormality associated with a medical condition, select a term for both the medical condition and the genetic marker or abnormality. Example
Example Reported LLT Selected Comment Weight loss Weight loss Unclear if the purpose is to induce weight loss or to treat an underweight patient Immunosuppression Immunosuppression Unclear if the purpose is to induce or to treat immunosuppression 3.26.2 Complex indications Term selection for some indications (e.g., in regulated product information) may be complex and require selection of more than one LLT to represent the information completely, depending on the circumstances. Example Reported LLT Selected Comment Treatment of aggression in autism Aggression The products do not treat the underlying autism, thalassemia, or myocardial infarction, but they do address the associated signs/symptoms (aggression, chronic iron overload, atherothrombosis). It may be necessary to select LLT Autism, LLT Thalassemia major, or LLT Myocardial infarction based on regional regulatory requirements. Treatment of chronic iron overload in thalassemia major Chronic iron overload Prevention of atherothrombotic events in patients with myocardial infarction prophylaxis 3.26.3 Indications with genetic markers or abnormalities For indications that describe a genetic marker or abnormality associated with a medical condition, select a term for both the medical condition and the genetic marker or abnormality. Example
9491-1610_termselptc_r4.6_sep2013.docx