SOCIAL QUESTIONS|health|pharmaceutical industry
- substaint ghníomhach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Context 'EUR 145200 i gcás ina n-áirítear trí shubstaint ghníomhacha agus/nó trí theaglaim de shubstaintí gníomhacha sa mheasúnú...' Reference "Rialachán (AE) Uimh. 658/2014 maidir le táillí is iníoctha leis an nGníomhaireacht Leigheasra Eorpach chun gníomhaíochtaí cógas-aireachais a dhéanamh i ndáil le táirgí íocshláinte lena n-úsáid ag an duine, CELEX:32014R0658/GA"
- substaint atá gníomhach ó thaobh na cógaseolaíochta de Reference "Rialachán (CE) Uimh. 470/2009 lena leagtar síos nósanna imeachta Comhphobail chun teorainneacha na n-iarmhar a bhunú do shubstaintí atá gníomhach ó thaobh na cógaseolaíochta de i mbia-ábhair de thionscnamh ainmhíoch, CELEX:32009R0470/GA"
- ga
- Wirkstoff | wirksamer Bestandteil | arzneilich wirksamer Bestandteil | pharmakologisch wirksamer Stoff | Arzneistoff
- de
- Definition Stoff, der bei der Herstellung eines Arzneimittels zu einem seiner pharmakologisch wirksamen Bestandteile wird Reference "Council-DE, vgl. Verordnung (EU) 2019/6 über Tierarzneimittel, Art. 4 Abs. 3"
- Comment """Anders formuliert sind Wirkstoffe also diejenigen Bestandteile eines Arzneimittels, die für seine Wirksamkeit verantwortlich sind."""
- active substance | pharmacologically active substance | active ingredient | therapeutic entity | therapeutic substance
- en
- Definition substance responsible for the pharmacological activity of a medicinal product Reference "COM-Terminology Coordination, based on: 'active substance' (26.7.2023). EMA. Glossary"
- Comment "The quantity of the active substance should be expressed per dosage unit (for metered dose inhalation products, per delivered dose and/or per metered dose), per unit volume, or per unit of weight and should be related to the declaration of strength in section 1. Quantity should be expressed in internationally recognised standard term which could be complemented with another term if more meaningful to healthcare professionals."