Gaois

A collection of legal and legislative terms in Irish extracted from the European Union’s multilingual terminology database. More information »

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 that is life-threatening" Reference "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"
Comment 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
effet indésirable grave
fr