Gaois

Cóip statach de shonraí a easpórtáiltear ó IATE ó am go chéile atá sa chnuasach seo. Níor cheart glacadh leis gurb ionann i gcónaí an t-eolas a thugtar faoi iontráil anseo agus a bhfuil sa leagan reatha den iontráil ar IATE. Is féidir an leagan reatha sin a cheadú ach cliceáil ar an nasc atá ar thaobh na láimhe deise ag barr gach iontrála. Breis eolais »

5 thoradh

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

    #639313

    IATE #2228848
    táirge íocshláinte ardteiripe Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Arzneimittel für neuartige Therapien
    de
    Sainmhíniú 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 Tagairt "Verordnung (EG) Nr. 1394/2007 über Arzneimittel für neuartige Therapien CELEX:32007R1394/DE (17.2.2009)"
    advanced therapy medicinal product | ATMP
    en
    Sainmhíniú 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 Tagairt "Regulation (EC) No 1394/2007 on advanced therapy medicinal products, Article 2(1)(a)"
    médicament de thérapie innovante | produit de thérapie innovante | MTI
    fr
    Nóta "notion plus restreinte que celle de produit de thérapie innovante [ IATE:2228511 ]"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #641405

    IATE #3501747
    comhtháirge íocshláinte ardteiripe Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    combined advanced therapy medicinal product | combined ATMP | combination ATMP
    en
    Sainmhíniú "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" Tagairt "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
    Sainmhíniú 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 Tagairt "CELEX:32007R1394/fr"
  3. SOCIAL QUESTIONS|health|pharmaceutical industry

    #641403

    IATE #3501745
    somatisches Zelltherapeutikum
    de
    somatic cell therapy medicinal product
    en
    Sainmhíniú biological medicinal product which has the following characteristics:a) contains or consists of cells or tissues that have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or of cells or tissues that are not intended to be used for the same essential function(s) in the recipient and the donor;b) is presented as having properties for, or is used in or administered to human beings with a view to treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues Tagairt "Directive 2001/83/EC on the Community code relating to medicinal products for human use"
    médicament de thérapie cellulaire somatique
    fr
  4. SOCIAL QUESTIONS|health|medical science · SOCIAL QUESTIONS|health|pharmaceutical industry

    #641402

    IATE #3501744
    táirge íocshláinte géinteiripe Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Gentherapeutikum
    de
    Sainmhíniú 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 Tagairt "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
    Sainmhíniú 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. Tagairt "Directive 2001/83/EC on the Community code relating to medicinal products for human use"
    Nóta Gene therapy medicinal products shall not include vaccines against infectious diseases.
    médicament de thérapie génique
    fr
    Sainmhíniú 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 Tagairt "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"
  5. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648655

    IATE #3543169
    táirge íocshláinte imscrúdaitheach ardteiripe Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Prüfpräparat für neuartige Therapien
    de
    Sainmhíniú Prüfpräparat, das ein Arzneimittel für neuartige Therapien im Sinne des Artikels 2 Absatz 1 der Verordnung (EG) Nr. 1394/2007 des Europäischen Parlaments und des Rates ist Tagairt COM-Internes Dokument SANCO-2012-80155-02-01
    advanced therapy investigational medicinal product
    en
    Sainmhíniú "advanced therapy medicinal product [ IATE:2228848 ] which is also an investigational medicinal product [ IATE:2146586 ]" Tagairt "COM-EN, based on:Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, CELEX:52012PC0369/EN"
    médicament expérimental de thérapie innovante
    fr
    Sainmhíniú "médicament expérimental correspondant à un médicament de thérapie innovante [ IATE:2228848 ]" Tagairt COM-Document interne: SANCO-2012-80155-00-04Règlement relatif aux essais cliniques de médicaments à usage humain