SOCIAL QUESTIONS|health|pharmaceutical industry
- frithghníomh trom díobhálach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- schwerwiegende Nebenwirkung
- de
- Nóta Term defined -- Term defined --
- serious adverse reaction
- en
- Sainmhíniú "adverse reaction that is life-threatening" Tagairt "COM-Terminology Coordination,, based on:- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use- Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products"
- Nóta It 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