Unclear if the purpose is Immunosuppression Immunosuppression to induce or to treat immunosuppression 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. Reported LLT Selected Comment Treatment of Aggression aggression in autism The products do not treat the underlying autism, thalassaemia, or myocardial Treatment of chronic Chronic iron infarction, but they do address the iron overload in overload associated signs/symptoms (aggression, thalassaemia major chronic iron overload, atherothrombosis). Prevention of It may be necessary to select LLT Autism, Atherothrombosis atherothrombotic LLT Thalassaemia major, or LLT prophylaxis events in patients Myocardial infarction based on regional with myocardial regulatory requirements. infarction 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 Reported LLT Selected cell lung cancer Non small cell lung cancer with K-ras mutation K-ras gene mutation Prevention and prophylaxis When an indication for prevention or prophylaxis is reported, select the specific MedDRA term, if it exists (Note: the words and are synonymous in the “prevention” “prophylaxis” context of MedDRA). Example Reported LLT Selected
Immunosuppression Immunosuppression Unclear if the purpose is to induce or to treat immunosuppression 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. Reported LLT Selected Comment Treatment of aggression in autism Aggression The products do not treat the underlying autism, thalassaemia, 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 Thalassaemia major, or LLT Myocardial infarction based on regional regulatory requirements. Treatment of chronic iron overload in thalassaemia major Chronic iron overload Prevention of atherothrombotic events in patients with myocardial infarction Atherothrombosis prophylaxis 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 Reported LLT Selected Non small cell lung cancer with K-ras mutation cell lung cancer K-ras gene mutation Prevention and prophylaxis When an indication for prevention or prophylaxis is reported, select the specific MedDRA term, if it exists (Note: the words “prevention” and “prophylaxis” are synonymous in the context of MedDRA). Example Reported LLT Selected
000012_termselptc_r4_13_mar2017_RL.docx