Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry · SCIENCE|natural and applied sciences|life sciences

    #639313

    IATE #2228848
    táirge íocshláinte ardteiripe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Arzneimittel für neuartige Therapien
    de
    Definition die folgenden Humanarzneimittel:- Gentherapeutika gemäß Anhang I Teil IV der Richtlinie 2001/83/EG,- somatische Zelltherapeutika gemäß Anhang I Teil IV der Richtlinie 2001/83/EG,- biotechnologisch bearbeitete Gewebeprodukte gemäß Buchstabe b Reference "Verordnung (EG) Nr. 1394/2007 über Arzneimittel für neuartige Therapien CELEX:32007R1394/DE (17.2.2009)"
    advanced therapy medicinal product | ATMP
    en
    Definition any of the following medicinal products for human use:- a gene therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC, or- a somatic cell therapy medicinal product as defined in Part IV of Annex I to Directive 2001/83/EC,or- a tissue engineered product as defined in point (b) of Article 2(1) of Regulation (EC) No 1394/2007 Reference "Regulation (EC) No 1394/2007 on advanced therapy medicinal products, Article 2(1)(a)"
    médicament de thérapie innovante | produit de thérapie innovante | MTI
    fr
    Comment "notion plus restreinte que celle de produit de thérapie innovante [ IATE:2228511 ]"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #641405

    IATE #3501747
    comhtháirge íocshláinte ardteiripe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    combined advanced therapy medicinal product | combined ATMP | combination ATMP
    en
    Definition "advanced therapy medicinal product that fulfils the following conditions: – it must incorporate, as an integral part of the product, one or more medical devices within the meaning of Article 1(2)(a) of Directive 93/42/EEC or one or more active implantable medical devices within the meaning of Article 1(2)(c) of Directive 90/385/EEC, and – its cellular or tissue part must contain viable cells or tissues, or – its cellular or tissue part containing non-viable cells or tissues must be liable to act upon the human body with action that can be considered as primary to that of the devices referred to" Reference "Regulation (EC) No 1394/2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004"
    médicament combiné de thérapie innovante
    fr
    Definition médicament de thérapie innovante qui satisfait aux conditions suivantes:- il doit incorporer comme partie intégrante un ou plusieurs dispositifs médicaux au sens de l’article 1er, paragraphe 2, point a), de la directive 93/42/CEE, ou bien un ou plusieurs dispositifs médicaux implantables actifs au sens de l’article 1er, paragraphe 2, point c), de la directive 90/385/CEE, et- sa partie cellulaire ou tissulaire doit contenir des cellules ou des tissus viables, ou- sa partie cellulaire ou tissulaire contenant des cellules ou des tissus non viables doit être susceptible d’avoir sur le corps humain une action qui peut être considérée comme essentielle par rapport à celle des dispositifs précités Reference "CELEX:32007R1394/fr"