SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product
- táirge íocshláinte tréidliachta hibrideach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Comhthéacs 'Féadfar na staidéir réamhchliniciúla nó na trialacha cliniciúla i gcomhair táirge íocshláinte tréidliachta hibrideach a dhéanamh le baisceanna den táirge íocshláinte tréidliachta tagartha arna údarú san Aontas nó i dtríú tír.' Tagairt "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
- hybrid veterinary medicinal product
- en
- Sainmhíniú "veterinary medicinal product that does not meet all the characteristics of a generic veterinary medicinal product [ IATE:3552434/EN ] because of one or more of the following reasons:(a) there are changes in the active substance or substances [ IATE:35093/EN ], indications for use, strength [ IATE:3518706/EN ], pharmaceutical form [ IATE:1106950/EN ] or route of administration [ IATE:1662444/EN ] of the generic veterinary medicinal product compared to the reference veterinary medicinal product [ IATE:3592261/EN ]; (b) bioavailability studies [ IATE:3518727/EN ] cannot be used to demonstrate bioequivalence [ IATE:1090485/EN ] with the reference veterinary medicinal product; or (c) there are differences relating to raw materials or in manufacturing processes [ IATE:3510058 ] of the biological veterinary medicinal product [ IATE:3552431/EN ] and the reference biological veterinary medicinal product" Tagairt "Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC"
- médicament vétérinaire hybride
- fr
- Sainmhíniú médicament vétérinaire similaire à un médicament de référence contenant le même principe actif mais ne présentant pas pour autant toutes les caractéristiques du médicament vétérinaire générique Tagairt COM-FR
- Nóta "Voir aussi:- médicament de référence [IATE:3541634 ]- médicament vétérinaire générique [IATE:3552434 ]"