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 »

46 toradh

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648660

    IATE #3543176
    táirge íocshláinte cúntach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Hilfspräparat
    de
    auxiliary medicinal product | auxiliary medicinal products
    en
    Sainmhíniú medicinal product used in the context of a clinical trial, but not as an investigational medicinal product Tagairt "Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, CELEX:32014R0536/EN"
    Nóta Auxiliary medicinal products do not include concomitant medications, i.e. medications unrelated to the clinical trial and not relevant for the design of the clinical trial.
    médicament auxiliaire
    fr
    Sainmhíniú médicament utilisé dans le contexte d'un essai clinique, mais non comme médicament expérimental Tagairt COM-Document interne: SANCO-2012-80155-00-04Règlement relatif aux essais cliniques de médicaments à usage humain
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #612038

    IATE #885035
    táirge íocshláinte dílleachtach Tagairt Comhairle-GA
    ga
    Comhthéacs """Ba cheart gur de réir oibleagáidí ar leith a dhéanfaí údaruithe margaíochta den sórt sin a dheonú. Ba cheart go mbeadh sna catagóirí táirgí íocshláinte lena n-úsáid ag an duine lena mbaineann na táirgí íocshláinte, lena n-áirítear táirgí íocshláinte dílleachtacha, a bhfuil sé mar aidhm leo galair thromchúiseacha dhíblitheacha nó is baol báis a chóireáil nó a chosc...""" Tagairt "Rialachán (AE) 2019/5 ó Pharlaimint na hEorpa agus ón gComhairle"
    druga dílleachta Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    táirge íocshláinte dílleachta Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Arzneimittel für seltene Leiden | Orphan-Arzneimittel | Humanarzneimittel für seltene Leiden
    de
    Sainmhíniú ein nach den Bestimmungen der Verordnung (EG) Nr. 141/2000 ausgewiesenes Arzneimittel (Orphan medicinal product) Tagairt "Verordnung (EG) Nr. 141/2000, Artikel 2 Buchstabe b CELEX:32000R0141/DE"
    Nóta "Gemäß der Verordnung (EG) Nr. 141/2000 sind dies nicht nur Arzneimittel für seltene Krankheiten (Kriterium: 5 Erkrankungen auf 10.000 Personen), sondern auch aus anderen Gründen nicht-rentable Arzneimittel (vgl. Artikel 3 Absatz 1 Buchstabe a).Die richtige Bezeichnung für ""Orphan disease""/""maladie orpheline"" im Deutschen lautet ""Waisenkrankheit"" oder ""Orphan-Krankheit"" (siehe IATE:139134 ). ""Seltene Krankheit"" steht dagegen für ""rare disease""/""maladie rare"" IATE:883096 ."
    orphan medicinal product | orphan medicine | orphan drug | orphan medicinal product for human use
    en
    Sainmhíniú medicinal product intended for the diagnosis, prevention or treatment of a life-threatening or very serious condition, where no other such product exists because it would not be economically viable to develop one and/or because the condition is rare Tagairt "Council-EN based on Regulation (EC) No 141/2000 on orphan medicinal products, Article 3 CELEX:02000R0141-20190726"
    Nóta "The regulatory designation as an 'orphan medicinal product' is associated with incentives intended to promote the development of such medicines.See also:- orphan disease, IATE:139134 - rare disease, IATE:883096<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>"
    médicament orphelin | médicament orphelin à usage humain
    fr
    Sainmhíniú médicament destiné à traiter une maladie grave et rare, à laquelle les investisseurs s'intéressent peu Tagairt "Délégation générale à la langue française et aux langues de France (DGLFLF), FranceTerme, http://www.culture.fr/franceterme/result?francetermeSearchTerme=medicament+orphelin&francetermeSearchDomaine=0&francetermeSearchSubmit=rechercher&action=search [22.10.2018]"
    Nóta "Dans le cadre juridique de l'Union européenne, un médicament orphelin est un médicament ainsi désigné dans les conditions prévues par le règlement n° 141/2000 concernant les médicaments orphelins. Conformément audit règlement, un médicament obtient la désignation de médicament orphelin si son promoteur peut établir:a) qu'il est destiné au diagnostic, à la prévention ou au traitement d'une affection entraînant une menace pour la vie ou une invalidité chronique ne touchant pas plus de cinq personnes sur dix mille dans la Communauté, au moment où la demande est introduite, ouqu'il est destiné au diagnostic, à la prévention ou au traitement, dans la Communauté, d'une maladie mettant la vie en danger, d'une maladie très invalidante ou d'une affection grave et chronique, et qu'il est peu probable que, en l'absence de mesures d'incitation, la commercialisation de ce médicament dans la Communauté génère des bénéfices suffisants pour justifier l'investissement nécessaireetb) qu'il n'existe pas de méthode satisfaisante de diagnostic, de prévention ou de traitement de cette affection ayant été autorisée dans la Communauté, ou, s'il en existe, que le médicament en question procurera un bénéfice notable à ceux atteints de cette affection.Conseil-FR, d'après le règlement n° 141/2000 concernant les médicaments orphelins, CELEX:02000R0141-20090807/FR Voir aussi:- maladie orpheline [IATE:139134 ]- maladie rare [IATE:883096 ]"
  3. SOCIAL QUESTIONS|health|pharmaceutical industry

    #651262

    IATE #3552427
    táirge íocshláinte faoi bhun caighdeáin Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    minderwertiges Arzneimittel
    de
    Sainmhíniú Produkt, dessen Zusammensetzung und Bestandteile nicht den korrekten wissenschaftlichen Spezifikationen entsprechen und das dadurch unwirksam und häufig auch gefährlich für den Patienten ist Tagairt "WHO zitiert nach EAASM (European Alliance for Access to Safe Medicines), http://www.eaasm.eu/counterfeit-medicines,de (6.10.2014)"
    substandard medicinal product | substandard medicine | substandard medicines
    en
    Sainmhíniú "pharmaceutical product [ IATE:1443220 ] that does not meet the quality standards and specifications" Tagairt "WHO. SIXTY-FOURTH WORLD HEALTH ASSEMBLY. Provisional agenda item 13.7. Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products, http://apps.who.int/gb/ssffc/pdf_files/A64_16-en.pdf [4.12.2013]"
    Nóta Each pharmaceutical product that a manufacturer produces has to comply with quality assurance standards and specifications, at release and throughout its shelf-life, according to the requirements of the territory of use. Normally, these standards and specifications are reviewed, assessed and approved by the applicable national or regional medicines regulatory authority before the product is authorized for marketing.
    médicament de qualité inférieure | produit médical de qualité inférieure
    fr
    Sainmhíniú médicaments ne répondant pas aux normes de sécurité, d’efficacité et de qualité en vigueur Tagairt "COM-FR, d'après Décision WHA63(10) de l’OMS relative aux «Produits médicaux de qualité inférieure/faux/faussement étiquetés/falsifiés/contrefaits», 63e Assemblée mondiale de la santé, avril 2010, http://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_DIV3-fr.pdf [12.8.2014]"
    Nóta "Voir aussi: médicament [IATE:1443220 ]"
  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 · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research

    #638255

    IATE #2146586
    táirge íocshláinte imscrúdaitheach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Prüfpräparat
    de
    Sainmhíniú pharmazeutische Form eines Wirkstoffs oder Placebos, die in einer klinischen Prüfung getestet oder als Referenzsubstanz verwendet wird Tagairt "Richtlinie 2001/20/EG des Europäischen Parlaments und des Rates vom 4. April 2001 zur Angleichung der Rechts- und Verwaltungsvorschriften der Mitgliedstaaten über die Anwendung der guten klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Humanarzneimitteln CELEX:32001L0020/DE"
    investigational medicinal product | IMP | investigational product | medicinal product for trial | investigational medicine
    en
    Sainmhíniú "medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial" Tagairt "Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC"
    Nóta Does not include medicinal products used for background treatment, challenge agents, rescue medication, or medicinal products used to assess end-points in a clinical trial.
    médicament expérimental
    fr
    Sainmhíniú médicament expérimenté ou utilisé comme référence, y compris en tant que placebo, lors d'un essai clinique Tagairt "Règlement (UE) n o 536/2014 relatif aux essais cliniques de médicaments à usage humain et abrogeant la directive 2001/20/CE"
  6. 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
  7. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648659

    IATE #3543175
    táirge íocshláinte imscrúdaitheach diagnóiseach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    diagnostisches Prüfpräparat
    de
    diagnostic investigational medicinal product
    en
    Sainmhíniú "investigational medicinal product [ IATE:2146586 ] used to make a medical diagnosis" Tagairt COM-EN, based on: COM-Internal document: SANCO-2012-80155-00-01 Regulation on clinical trials on medicinal products for human use
    médicament expérimental de diagnostic
    fr
    Sainmhíniú médicament expérimental utilisé pour réaliser un diagnostic Tagairt COM-FR, d'après:COM-Document interne: SANCO-2012-80155-00-04Règlement relatif aux essais cliniques de médicaments à usage humain
  8. SOCIAL QUESTIONS|health|health policy · SOCIAL QUESTIONS|health|pharmaceutical industry

    #647272

    IATE #3535658
    táirge íocshláinte lena úsáid ag an duine Tagairt "Rialachán (AE) Uimh. 1235/2010 lena leasaítear, maidir le cógas-aireachas ar tháirgí íocshláinte lena n-úsáid ag an duine, Rialachán (CE) Uimh. 726/2004 lena leagtar síos nósanna imeachta Comhphobail maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus le haghaidh úsáide tréidliachta agus lena mbunaítear Gníomhaireacht Leigheasra Eorpach, agus Rialachán (CE) Uimh. 1394/2007 maidir le táirgí íocshláinte ardteiripe, CELEX:32010R1235/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Comhthéacs 'Déantar roinnt táirgí íocshláinte lena n-úsáid ag an duine a údarú, áfach, faoi réir an choinníll go ndéanfar faireachán breise orthu. Áirítear ina measc sin gach táirge íocshláinte lena úsáid ag an duine a bhfuil substaint ghníomhach nua ann agus táirgí íocshláinte bitheolaíochta lena n-áirítear bithshamhlacha ar tosaíochtaí iad don chógas-aireachas.' Tagairt "Rialachán (AE) Uimh. 1235/2010 lena leasaítear, maidir le cógas-aireachas ar tháirgí íocshláinte lena n-úsáid ag an duine, Rialachán (CE) Uimh. 726/2004 lena leagtar síos nósanna imeachta Comhphobail maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus le haghaidh úsáide tréidliachta agus lena mbunaítear Gníomhaireacht Leigheasra Eorpach, agus Rialachán (CE) Uimh. 1394/2007 maidir le táirgí íocshláinte ardteiripe, CELEX:32010R1235/GA"
    Humanarzneimittel
    de
    medicinal product for human use
    en
    Sainmhíniú in the framework of Directive 2001/83/EC, any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis Tagairt "Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, CELEX:02001L0083-20121116/EN"
    Nóta "See also:- IATE:773210 ""veterinary medicinal product; medicinal product for veterinary use"" - IATE:793544 ""medicinal product"""
    médicament à usage humain
    fr
  9. SOCIAL QUESTIONS|health|pharmaceutical industry

    #615813

    IATE #928764
    táirge íocshláinte luibhe Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    pflanzliches Arzneimittel
    de
    Sainmhíniú Arzneimittel, das als Wirkstoff(e) ausschließlich einen oder mehrere pflanzliche Stoffe oder eine oder mehrere pflanzliche Zubereitungen oder eine oder mehrere solcher pflanzlichen Stoffe in Kombination mit einer oder mehreren solcher pflanzlichen Zubereitungen enthält Tagairt "Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel hinsichtlich traditioneller pflanzlicher Arzneimittel, CELEX:02001L0083/DE , Artikel 1 Absatz 30, angefügt durch Richtlinie 2001/83/EG, CELEX:32004L0024/DE , Artikel 1 Absatz 1"
    herbal medicinal product | herbal medicine
    en
    Sainmhíniú medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations Tagairt "Directive 2001/83/EC on the Community code relating to medicinal products for human use"
    médicament à base de plantes
    fr
  10. SOCIAL QUESTIONS|health|pharmaceutical industry

    #652483

    IATE #3557546
    táirge íocshláinte neamh-réamhullmhaithe Tagairt Comhairle-GA
    ga
    fallweise zubereitetes Arzneimittel
    de
    medicinal product prepared extemporaneously | extemporaneous preparation | extemporaneously prepared medicine | extemporaneously prepared medicinal product | medicine prepared extemporaneously | extemporaneous mixture | drug prepared by a pharmacist on prescription | extemporaneous formulation
    en
    Sainmhíniú medicinal product prepared to the special requirements of a patient following the prescription of a doctor or prepared to the formula of an official pharmacopoeia or prepared from authorised dosage forms and commercial or locally-produced suspending agents Tagairt "COM-Terminology Coordination, based on: T. Nunn, S. Hill. Report for WHO on findings of a review of existing guidance/advisory documents on how medicines should be administered to children, including general instructions on compounding preparations and manipulation of adult dosage forms. WHO, August 2011, http://www.who.int/medicines/areas/quality_safety/quality_assurance/Review-findings-PaediatricMedicnesAdmin_QAS11-400Rev1_22082011.pdf [22.11.2013]"
    Nóta "The medicinal products can be prepared by a private pharmacy or by a pharmacy of a health structure. See also:- officinal formula (narrower) [ IATE:783219 ]- magistral formula (narrower) [ IATE:764448 ]"
    préparation extemporanée
    fr
    Sainmhíniú médicament préparé au moment du besoin pour un patient donné, selon les prescriptions d'un médecin ou suivant la pharmacopée ou le formulaire national Tagairt "COM-FR, d'après CNRTL > Extemporané, http://www.cnrtl.fr/lexicographie/extemporan%E9 [14.8.2014]"
    Nóta "Voir aussi:- formule officinale [IATE:783219 ]- formule magistrale [IATE:764448 ]"
  11. SOCIAL QUESTIONS|health|pharmaceutical industry

    #602461

    IATE #159306
    táirge íocshláinte péidiatraiceach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Kinderarzneimittel | Pharmazeutika für Kinder | pädiatrische Arzneimittel
    de
    paediatric medicinal product | paediatric medicine | paediatric drug | medicinal product for use in the paediatric population | medicinal product for children | pediatric medicinal product | pediatric medicine | pediatric drug | medicinal product for use in the pediatric population
    en
    Sainmhíniú medicinal product used to treat persons aged 0-18 Tagairt "COM-Terminology Coordination, based on:Regulation (EC) No 1901/2006 on medicinal products for paediatric use"
    médicament pédiatrique | médicament à usage pédiatrique
    fr
    Sainmhíniú médicament destiné aux enfants Tagairt "Organisation mondiale de la santé, Médicaments: médicaments destinés aux enfants, http://www.who.int/mediacentre/factsheets/fs341/fr/ [12.12.2013]"
  12. SOCIAL QUESTIONS|health|medical science · SOCIAL QUESTIONS|health|health policy|organisation of health care|blood transfusion

    #616112

    IATE #930943
    táirge íocshláinte plasmadhíorthach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Plasmaderivat | Plasmaderivate | Arzneimittel aus Blutplasma
    de
    plasma product | plasma derivative | plasma-derived medicinal product
    en
    Sainmhíniú medicinal product with plasma-derived proteins as active substances, investigational medicinal product with plasma proteins as active substances, medicinal product or investigational medicinal product in which plasma derived proteins are used as excipients, medical device where plasma derived proteins are used as ancilliary substances Tagairt "COM-Terminology Coordination, based on: EMA. 'Guideline on plasma-derived medicinal products' (23.2.2023). EMA/CHMP/BWP/706271/2010. 21 July 2011"
    dérivé plasmatique
    fr
  13. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product|medicament · TRADE|marketing

    #663497

    IATE #3589745
    táirge íocshláinte seanbhunaithe Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    mature medicinal product | mature pharmaceutical | mature product | cornerstone
    en
    Sainmhíniú drug that has been on the market for a long period of time Tagairt "COM-Terminology Coordination, based on: Blandine Lasbax. 'Challenges of mature drugs in the pharmaceutical industry: issues of multichannel strategies' (14.5.2020). Pharmaceutical sciences. 2012. dumas-01435258"
    Nóta There is no official definition for a mature or maturing drug. We can however say that, essentially, they are the opposite of newly launched drugs.
    médicament mature
    fr
    Sainmhíniú médicament dont le brevet est sur le point de tomber ou est déjà tombé dans le domaine public Tagairt "COM-FR d'après le rapport final du PIPAME (mars 2017) ""Enjeux et perspectives des producteurs pour tiers de principes actifs et de médicaments"" (14.5.2020)"
  14. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648380

    IATE #3541634
    táirge íocshláinte tagartha Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Referenzarzneimittel
    de
    reference medicinal product | reference medicine | reference product
    en
    Sainmhíniú medicinal product authorised in accordance with European Union law before being placed on the market and to which the application for marketing authorisation for a generic/hybrid medicinal product refers, by demonstration of bioequivalence, usually through the submission of the appropriate bioavailability studies Tagairt COM-Terminology Coordination, based on:
    médicament de référence | médicament princeps
    fr
    Sainmhíniú version d’origine d’un médicament Tagairt "Site du ministère des affaires sociales et de la santé, Médicaments.gouv.fr, Glossaire, Médicament de référence, http://www.sante.gouv.fr/medicaments,1969.html [12.8.2014]"
    Nóta "Le médicament de référence ou médicament princeps est protégé par un brevet, généralement pendant 20 ans. Après l’expiration de ce brevet, des médicaments génériques peuvent être mis sur le marché.Source: Site du ministère des affaires sociales et de la santé [12.8.2014]Voir aussi: médicament générique [IATE:766172 ]"
  15. SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product

    #622736

    IATE #1225197
    táirge íocshláinte tréidliachta Tagairt "Seasamh ó Pharlaimint na hEorpaa glacadh ar an gcéad léamh an 23 Deireadh Fómhair 2013 chun go nglacfaí Rialachán (AE) Uimh. .../2013 ó Pharlaimint na hEorpa agus ón gComhairle lena leasaítear Rialachán (CE) Uimh. 111/2005 ón gComhairle lena leagtar síos rialacha chun faireachán a dhéanamh ar an trádáil i réamhtheachtaithe drugaí idir an Comhphobal agus tríú tíortha, http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+TC+P7-TC1-COD-2012-0250+0+DOC+PDF+V0//GA [2.7.2018] Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Comhthéacs 'Luafar san iarratas ar údarú margaíochta láraithe le haghaidh táirge íocshláinte tréidliachta ainm amháin don táirge íocshláinte tréidliachta a úsáidfear ar fud an Aontais.' Tagairt "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    táirge míochaine tréidliachta Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs 'Beidh an tréimhse aistarraingthe idir táirge míochaine tréidliachta allapatach a sintéisíodh go ceimiceach, lena n-áirítear antaibheathach, a úsáid den uair dheiridh ar ainmhí faoi ghnáthchionníollacha úsáide, agus bia-earraí a tháirgeadh ó ainmhí den chineál sin, dhá oiread chomh fada leis an tréimhse aistarraingthe dá dtagraítear in Airteagal 11 de Threoir 2001/82/CE, agus 48 n-uaire an chloig ar a laghad.' Tagairt "Rialachán (AE) 2018/848 maidir le táirgeadh orgánach agus lipéadú táirgí orgánacha agus lena leasaítear Rialachán (CE) Uimh. 834/2007 ón gComhairle, CELEX:32018R0848/GA"
    Tierarzneimittel
    de
    Sainmhíniú Stoff oder Stoffzusammensetzung, der/die als Mittel mit Eigenschaften zur Heilung oder zur Verhütung von Tierkrankheiten bestimmt ist, oder der/die im oder am tierischen Körper verwendet oder einem Tier verabreicht werden kann, um entweder die physiologischen Funktionen durch eine pharmakologische, immunologische oder metabolische Wirkung wiederherzustellen, zu korrigieren oder zu beeinflussen, oder eine medizinische Diagnose zu erstellen Tagairt "vgl. Legaldefinition in Richtlinie 2001/82/EG zur Schaffung eines Gemeinschaftskodexes für Tierarzneimittel, ABl. L_311/2001 CELEX:02001L0082-20090807/DE"
    veterinary medicinal product | VMP | veterinary drug | veterinary medicine | VMPs
    en
    Sainmhíniú substance or combination of substances which fulfils at least one of the following conditions:(a) it is presented as having properties for treating or preventing disease in animals;(b) its purpose is to be used in, or administered to, animals with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action;(c) its purpose is to be used in animals with a view to making a medical diagnosis;(d) its purpose is to be used for euthanasia of animals Tagairt "Regulation (EU) 2019/6 on veterinary medicinal products"
    Nóta "Regulation (EU) 2019/6 on veterinary medicinal products"
    médicament vétérinaire | médicament à usage vétérinaire
    fr
    Sainmhíniú toute substance ou composition présentée comme possédant des propriétés curatives ou préventives à l'égard des maladies animales Tagairt directive 2001/82/CE, art.1.2, JOCE L311/2001
  16. SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product

    #665612

    IATE #3599494
    táirge íocshláinte tréidliachta a diúltaíodh Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs 'Aon táirge íocshláinte tréidliachta a chuaigh in éag, aon táirge íocshláinte tréidliachta a aisghaireadh agus aon táirge íocshláinte tréidliachta a diúltaíodh, déanfar iad a leithscaradh láithreach go fisiceach agus déanfar iad a stóráil i limistéar tiomnaithe atá glan ar gach táirge íocshláinte tréidliachta eile. Cuirfear leibhéal iomchuí slándála i bhfeidhm sna limistéir sin chun a áirithiú go bhfágtar na hítimí sin i mball ar leith ón stoc indíolta. Déanfar na limistéir sin a shainaithint go soiléir.' Tagairt "Rialachán Cur Chun Feidhme (AE) 2021/1248 maidir le bearta i ndáil le dea-chleachtas dáileacháin do tháirgí íocshláinte tréidliachta i gcomhréir le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R1248/GA"
    zurückgewiesenes Tierarzneimittel
    de
    rejected veterinary medicinal product
    en
    Sainmhíniú "returned veterinary medicinal product that does not meet all the conditions to be returned to saleable stock by the wholesale distributor and must be destroyed" Tagairt "COM-EN, based on:Implementing Regulation (EU) 2021/1248 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6"
    médicament vétérinaire refusé
    fr
    Sainmhíniú "médicament vétérinaire retourné non conforme aux spécifications établies identifié comme tel, mis en quarantaine, puis refusé" Tagairt "COM-FR d'après Règlement d’exécution (UE) 2021/1248 de la Commission du 29 juillet 2021 concernant les mesures relatives aux bonnes pratiques de distribution des médicaments vétérinaires conformément au règlement (UE) 2019/6 du Parlement européen et du Conseil"
  17. SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product

    #651265

    IATE #3552431
    táirge íocshláinte tréidliachta bitheolaíoch Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs '... tá difríochtaí ann a bhaineann le hamhábhair nó idir próisis mhonaraíochta an táirge íocshláinte tréidliachta bhitheolaíoch agus an táirge íocshláinte tréidliachta bhitheolaíoch tagartha.' Tagairt "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    Sainmhíniú táirge íocshláinte tréidliachta inar substaint bhitheolaíoch í an tsubstaint ghníomhach Tagairt "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    biological veterinary medicinal product | veterinary biological medicinal product
    en
    Sainmhíniú "veterinary medicinal product where an active substance is a biological substance" Tagairt "Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC "
  18. SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product

    #651266

    IATE #3552434
    táirge íocshláinte tréidliachta cineálach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs 'I gcás ina dtíolacfar roinnt foirmeacha cógaisíochta béil pras-scaoilte de tháirge íocshláinte tréidliachta cineálach, measfar gurb ionann iad agus aon fhoirm chógaisíochta amháin.' Tagairt "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    generisches Tierarzneimittel
    de
    Sainmhíniú Tierarzneimittel, das die gleiche qualitative und quantitative Zusammensetzung aus Wirkstoffen und die gleiche Darreichungsform wie das Referenzarzneimittel aufweist und dessen Bioäquivalenz mit dem Referenzarzneimittel durch geeignete Bioverfügbarkeitsstudien nachgewiesen wurde Tagairt "Vorschlag für eine Verordnung über Tierarzneimittel COM/2014/0558 final CELEX:52014PC0558/DE"
    generic veterinary medicinal product
    en
    Sainmhíniú "veterinary medicinal product which has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference veterinary medicinal product, and with regard to which bioequivalence with the reference veterinary medicinal product has been demonstrated" Tagairt "Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC "
    médicament vétérinaire générique | médicament générique à usage vétérinaire
    fr
    Sainmhíniú copie d’un médicament vétérinaire original (ou spécialité de référence) devant avoir la même composition en principes actifs, la même forme pharmaceutique (comprimé, pommade…) et les mêmes effets dans l’organisme Tagairt "COM-FR, d’après le site du ministère des Affaires sociales et de la Santé > Médicaments.gouv.fr > Glossaire > Médicament générique, http://www.sante.gouv.fr/medicaments,1969.html [12.8.2014]"
    Nóta "Le médicament vétérinaire générique peut toutefois présenter des différences avec le médicament de référence [IATE:65577], notamment d’autres excipients, qui ne sont tolérées qu’à condition qu’elles n’affectent pas la bioéquivalence du médicament générique par rapport au médicament de référence, seule garantie d’une activité thérapeutique identique.Source: Site du ministère des Affaires sociales et de la Santé [12.8.2014]Voir aussi:- médicament de référence [IATE:65577 ]- bioéquivalence [IATE:1090485 ]"
  19. SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product

    #664568

    IATE #3592263
    táirge íocshláinte tréidliachta géinteiripe Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs '... 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.' Tagairt "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 Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    gene therapy veterinary medicinal product | gene therapy product
    en
    Sainmhíniú "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" Tagairt "COM-Terminology Coordination, based on: Commission Delegated Regulation (EU) 2021/805 amending Annex II to Regulation (EU) 2019/6"
  20. SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product

    #651288

    IATE #3552480
    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"
    hybrides Tierarzneimittel
    de
    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 ]"