Gaois

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2 results

  1. SOCIAL QUESTIONS|health|medical science · SOCIAL QUESTIONS|health|pharmaceutical industry

    #641402

    IATE #3501744
    táirge íocshláinte géinteiripe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Gentherapeutikum
    de
    Definition Arzneimittel, bei dem durch eine Reihe von Verarbeitungsgängen der (in vivo oder ex vivo erfolgende) Transfer eines prophylaktischen, diagnostischen oder therapeutischen Gens (d. h. eines Stücks Nukleinsäure) in menschliche oder tierische Zellen und dessen anschließende Expression in vivo bewirkt werden sollen Reference "Richtlinie 2003/63/EG der Kommission vom 25. Juni 2003 zur Änderung der Richtlinie 2001/83/EG des Europäischen Parlaments und des Rates zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel CELEX:32003L0063/DE"
    gene therapy medicinal product
    en
    Definition biological medicinal product which has the following characteristics:(a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence;(b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence. Reference "Directive 2001/83/EC on the Community code relating to medicinal products for human use"
    Comment Gene therapy medicinal products shall not include vaccines against infectious diseases.
    médicament de thérapie génique
    fr
    Definition tout produit obtenu par un ensemble de procédés de fabrication visant au transfert, in vivo ou ex vivo, d'un gène prophylactique, diagnostique ou thérapeutique (à savoir un morceau d'acide nucléique), vers des cellules humaines/animales et son expression consécutive in vivo Reference "Directive 2003/63/CE de la Commission, du 25 juin 2003, modifiant la directive 2001/83/CE du Parlement européen et du Conseil instituant un code communautaire relatif aux médicaments à usage humain , http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32003L0063:FR:HTML"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product

    #664568

    IATE #3592263
    táirge íocshláinte tréidliachta géinteiripe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context '... maidir le táirgí teiripe frithbhríche RNA agus teiripe trasnaíochta RNA a bheartaítear don ghéinteiripe, cuirfear san áireamh na ceanglais maidir le táirge íocshláinte tréidliachta géinteiripe.' Reference "Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA"
    táirge géinteiripe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    gene therapy veterinary medicinal product | gene therapy product
    en
    Definition "biological veterinary medicinal products that contain an active substance which contains or consists of a recombinant nucleic acid used in or administered to animals with a view to regulating, repairing, replacing, adding or deleting a genetic sequence and whose therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence they contain, or to the product of genetic expression of this sequence" Reference "COM-Terminology Coordination, based on: Commission Delegated Regulation (EU) 2021/805 amending Annex II to Regulation (EU) 2019/6"