医療用医薬品は、引渡し時点で予見し得る副作用について、製造物としての使用のために必要な情報が適切に与えられることにより、製造物責任法２条２項にいう「通常有すべき安全性」が確保される。 医療用医薬品の添付文書に記載されている副作用の情報が、製造物責任法２条２項にいう「通常有すべき安全性」を確保しているといえるかは、当該医療用医薬品の引渡し時点で予見し得る副作用の内容ないし程度（その発現頻度を含む。）、その効能又は効果から通常想定される処方者ないし使用者の知識及び能力、上記添付文書における副作用に係る記載の形式ないし体裁等の諸般の事情を総合考慮して、上記予見し得る副作用の危険性が上記処方者等に十分明らかにされているといえるか否かという観点から判断すべきである。
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