SOCIAL QUESTIONS|health|pharmaceutical industry
- frithghníomh trom díobhálach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- schwerwiegende Nebenwirkung
- de
- Comment Term defined -- Term defined --
- serious adverse reaction
- en
- Definition adverse reaction [ IATE:1146946 ] that is life-threatening; results in death or a persistent or significant disability or incapacity; manifests itself as a congenital anomaly/birth defect; or, in the case of the treatment of humans, requires inpatient hospitalisation or prolongation of existing hospitalisation or, in the case of the treatment of animals, results in permanent or prolonged signs in the animals treated Reference EP-EN Terminology, based on:- Directive 2001/83/EC on the Community code relating to medicinal products for human use, CELEX:32001L0083/EN - Directive 2001/82/EC on the Community code relating to veterinary medicinal products, CELEX:32001L0082/EN