Gaois

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31 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product|medicament

    #685878

    IATE #3591668
    teiripeach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Language usage "Is ainmfhocal é seo.N.B. Úsáideadh an focal 'teiripic' ar 'therapeutic(s)' sa chiall seo i gConclúidí ón gComhairle Mhí Mheithimh 2021 ach is téarma é sin a chuireann síos ar an bhráinse eolaíochta, ní ar tháirgí cógasaíochta, féach 1546773"
    táirge teiripeach Reference Comhairle-GA
    ga
    Language usage "Is ainmfhocal é seo.N.B. Úsáideadh an focal 'teiripic' ar 'therapeutics' i gConclúidí ón gComhairle Mhí Mheithimh 2021 ach is téarma é sin a chuireann síos ar an bhráinse eolaíochta, féach 1546773"
    Context '...a ndearnadh staidéar leordhóthanach ar an táirge teiripeach ina leith agus ar cinneadh go bhfuil sé sábháilte, éifeachtach.' Reference "Rialachán (AE) 2017/746 maidir le feistí leighis diagnóiseacha in vitro"
    druga teiripeach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    The­ra­peu­ti­kum
    de
    Comment "XREF:therapeutische Behandlung Arzneimittel, Medikament (EN medicinal product, medicine, pharmaceutical, drug)"
    therapeutic | drug | pharmaceutical drug
    en
    Definition product used to treat or cure a disease Reference European Commission. DG SANTE. Correspondence dated 5.11.2020
    Comment "1) In contrast to a medicinal product used to prevent a disease (i.e. vaccines and drugs used as prophylactic treatment). Symptomatic treatements are included.2) It is broader than ""medicinal product"" because ""convalescent plasma"" is not considered by the EU legislation as a ""medicinal product""; its manufacture though falls under the pharmaceutical legislation."
    traitement | produit thérapeutique | substance thérapeutique
    fr
    Definition produit utilisé dans le traitement d'une maladie Reference "Conseil-FR, d'après:- Site du Dictionnaire de l'Académie française de médecine > ""thérapeutique"" (23.6.2021)- Le Petit Robert de la langue française > ""thérapeutique"" (5.8.2021)"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #681934

    IATE #2250862
    luach teiripeach breise Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Arna iarraidh sin don Choimisiún, baileoidh an Ghníomhaireacht, maidir le táirgí íocshláinte údaraithe lena n‑úsáid ag an duine, aon fhaisnéis atá ar fáil i leith na modhanna a úsáideann údaráis inniúla na mBallstát chun an luach teiripeach breise a sholáthraíonn aon táirge íocshláinte nua lena n‑úsáid ag an duine a chinneadh.' Reference "Togra le haghaidh Rialachán lena leagtar síos nósanna imeachta Aontais maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus lena mbunaítear rialacha lena rialaítear an Ghníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (CE) Uimh. 1394/2007 agus Rialachán (AE) Uimh. 536/2014 agus lena n-aisghairtear Rialachán (CE) Uimh. 726/2004, Rialachán (CE) Uimh. 141/2000 agus Rialachán (CE) Uimh. 1901/2006, CELEX:52023PC0193/GA"
    therapeutischer Mehrwert
    de
    added therapeutic value | ATV | therapeutic added value
    en
    Definition clinical effectiveness of a medicinal product compared with other treatments Reference "COM-Terminology Coordination, based on: Communication from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions - A Stronger European-based Pharmaceutical Industry for the Benefit of the Patient - A Call for Action, COM(2003) 383"
    Comment There is no universally agreed definition of major therapeutic advantage or added therapeutic value, and different stakeholders (medical journals, HTA bodies, payers) apply different definitions according to their remit: some of these consider parameters that go beyond the current legal framework for medicines.
    valeur ajoutée thérapeutique | valeur thérapeutique ajoutée | VAT
    fr
    Definition Dans le cas d'un médicament, son efficacité clinique par rapport à d'autres traitements. Reference ---
  3. INTERNATIONAL RELATIONS|international affairs|international agreement · SOCIAL QUESTIONS|health|health policy · INTERNATIONAL RELATIONS|international affairs|international instrument|international convention|European convention · INTERNATIONAL ORGANISATIONS|European organisations|European organisation|Council of Europe

    #605275

    IATE #775461
    Prótacal breise a ghabhann leis an gComhaontú Eorpach maidir le Malartú Substaintí Teirpeacha de Bhunús Daonna Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Zusatzprotokoll zu dem Europäischen Übereinkommen über den Austausch therapeutischer Substanzen menschlichen Ursprungs
    de
    Comment Strassburg, 01.01.1983
    Additional Protocol to the European Agreement on the Exchange of Therapeutic Substances of Human Origin
    en
    Comment "Signed: Strasbourg, 1.1.1983Entry into force: 1.1.1985European Treaty Series (ETS) No. 109Authentic versions: EN-FRSince its entry into force, this Protocol forms an integral part of Agreement ETS 026 ( IATE:769182 )"
    Protocole additionnel à l'Accord européen relatif à l'échange de substances thérapeutiques d'origine humaine
    fr
    Definition "protocole additionnel permettant à l'Union européenne de devenir Partie à l'Accord IATE:769182 par signature de celui-ci" Reference "site Council of Europe, résumé du traité, http://conventions.coe.int/Treaty/fr/Summaries/Html/026.htm (28.3.2012)"
    Comment Signature: 1.1.1983 à StrasbourgEntrée en vigueur:1.1.1985Conseil de l'Europe; STCE n° 109Versions authentiques: EN-FR
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #615973

    IATE #929795
    an cód Ceimiceach Teiripeach Anatamaíoch Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Anatomisch-Therapeutisch-Chemische Klassifikation | ATC-Klassifikation
    de
    Definition System zur Einteilung der Wirkstoffe in Arzneimitteln entsprechend dem Organ oder Organsystem, auf das sie einwirken, und nach ihren chemischen, pharmakologischen und therapeutischen Eigenschaften in verschiedene Gruppen Reference "Analytik News, http://www.analytik-news.de/Presse/2004/17.html (5.7.2012)"
    Anatomical Therapeutic Chemical code | ATC code
    en
    Definition five-level code used as an identifier for active substances included in the ATC classification system, according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties Reference "COM-EN, based on:WHO Collaborating Centre for Drug Statistics Methodology. ATC. Structure and principles http://www.whocc.no/atc/structure_and_principles/ [14.5.2012]"
    code ATC | code Anatomique, thérapeutique, chimique
    fr
  5. SOCIAL QUESTIONS|health|pharmaceutical industry

    #678250

    IATE #1186701
    druga frithvíreasach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    frithvíreasach teiripeach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    frithvíreasach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Go háirithe, tá ról tábhachtach ag frithvíreasaigh agus ag antasubstaintí monaclóineacha frithvíreasacha chun cóireáil a chur ar othair a bhfuil COVID-19 orthu.' Reference "Teachtaireacht maidir le hUllmhacht agus Freagairt an Aontais a Chothú: Ag breathnú chun cinn, CELEX:52022DC0190/GA"
    antiviral drug | antiviral | antiviral medicine | antiviral medication | antiviral therapeutic
    en
    Definition class of medication used specifically for treating viral infections Reference "Wikipedia > Antiviral Drug (30.4.2021)"
    médicament antiviral | antiviral
    fr
  6. INTERNATIONAL RELATIONS|international affairs|international agreement · SOCIAL QUESTIONS|health|health policy · INTERNATIONAL RELATIONS|international affairs|international instrument|international convention|European convention · INTERNATIONAL ORGANISATIONS|European organisations|European organisation|Council of Europe

    #604944

    IATE #769182
    an Comhaontú Eorpach maidir le Malartú Substaintí Teirpeacha de Bhunús Daonna Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Europäisches Übereinkommen über den Austausch therapeutischer Substanzen menschlichen Ursprungs
    de
    Comment Paris, 15.12.1958
    European Agreement on the Exchange of Therapeutic Substances of Human Origin
    en
    Definition agreement aiming to ensure mutual assistance between parties in the supply of therapeutic substances of human origin should the need arise. Reference "Council-EN, based on Council of Europe Treaty Office summary (Treaty No. 026) (25.2.2020)"
    Comment "Signed: Paris, 15.12.1958Entry into force: 1.1.1959European Treaty Series (ETS) No. 026Additional Protocol ETS No. 109 ( IATE:775461 ) provides for the accession of the European Economic Community to the Agreement by signing it and since its entry into force forms an integral part of this Agreement."
    Accord européen relatif à l'échange de substances thérapeutiques d'origine humaine
    fr
    Definition accord dont l'objectif est d'apporter une assistance mutuelle en vue de la fourniture des substances thérapeutiques d'origine humaine Reference "site Conseil de l'Europe, résumé du traité, http://conventions.coe.int/Treaty/fr/Summaries/Html/026.htm (22.3.2012)"
    Comment Signature: 15.12.1958 à ParisEntrée en vigueur: 1.1.1959Conseil de l'Europe; STCE n° 026Versions authentiques: EN-FR
  7. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688248

    IATE #3639983
    dul chun cinn teiripeach eisceachtúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context '... níl aon táirge íocshláinte údaraithe le haghaidh an ghalair sin san Aontas nó léiríonn an t‑iarratasóir, d’ainneoin táirgí íocshláinte a bheith údaraithe le haghaidh an ghalair sin san Aontas, go ndéanfaidh an táirge dul chun cinn teiripeach eisceachtúil, anuas ar an tairbhe mhór a bheidh le baint as ...' Reference "Togra le haghaidh Rialachán lena leagtar síos nósanna imeachta Aontais maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus lena mbunaítear rialacha lena rialaítear an Ghníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (CE) Uimh. 1394/2007 agus Rialachán (AE) Uimh. 536/2014 agus lena n-aisghairtear Rialachán (CE) Uimh. 726/2004, Rialachán (CE) Uimh. 141/2000 agus Rialachán (CE) Uimh. 1901/2006, CELEX:52023PC0193/GA"
    exceptional therapeutic advancement
    en
  8. SOCIAL QUESTIONS|health|pharmaceutical industry · SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product|homeopathic product

    #687641

    IATE #3636826
    táirge íocshláinte hoiméapatach gan tásca teiripeacha formheasta Reference "Togra le haghaidh Treoir maidir le Cód an Aontais a bhaineann le táirgí íocshláinte lena n‑úsáid ag an duine, agus lena n‑aisghairtear Treoir 2001/83/CE agus Treoir 2009/35/CE, CELEX:52023PC0192/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    homeopathic medicinal product without approved therapeutic indications
    en
  9. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product · SOCIAL QUESTIONS|health|medical science|medical research

    #685563

    IATE #3589144
    teiripic imscrúdaitheach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    gníomhaí teiripeach imscrúdaitheach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Prüftherapeutikum
    de
    investigational therapeutic | investigational therapeutic agent
    en
    Definition experimental drug that is being tested for covid-19 Reference COM-Terminology Coordination
    traitement expérimental | agent thérapeutique expérimental
    fr
  10. SOCIAL QUESTIONS|health|pharmaceutical industry

    #683927

    IATE #3566893
    druga a bhfuil innéacs teiripeach íseal aige Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    narrow therapeutic index drug | NTID
    en
    Definition drug with small difference between therapeutic and toxic dose Reference "Pharmacy Practice http://www.pharmacypractice.org/vol08/pdf/050-055.pdf [16.10.2015]"
    Comment "see also therapeutic index [ IATE:1105803 ]"
    médicament à marge thérapeutique étroite | médicament à index thérapeutique faible | médicament à index thérapeutique étroit | médicament à indice thérapeutique étroit | médicament à indice thérapeutique faible
    fr
    Definition médicament pour lequel l’écart entre les concentrations efficaces et toxiques est faible Reference "Conseil-FR, d'après Martinez C., thèse pour le diplôme d'Etat de docteur en pharmacie, ""Perception du médicament générique par les patients de Midi-Pyrénées: les catégories socio-professionnelles ont-elles une influence?"", 12.6.2014, http://thesesante.ups-tlse.fr/550/1/2014TOU32021.pdf [21.1.2016]"
    Comment "Ce type de médicament se retrouve principalement dans les classes thérapeutiques suivantes (cette liste n’est cependant pas exhaustive): antiarythmiques, antiépileptiques, anticoagulants oraux, digitaliques, immunosupresseurs, théophylline et dérivés (cf. http://www.fagg-afmps.be/fr/items-HOME/Generiques/Securite_efficacite_bioequivalence/ [21.1.2016]).Voir IATE:1105803 (""indice thérapeutique""/""index thérapeutique"")."
  11. SOCIAL QUESTIONS|health|pharmaceutical industry

    #668930

    IATE #3639137
    eintiteas teiripeach nua Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comment <<<_not_supplied_>>>
    neuer therapeutischer Wirkstoff
    de
    new therapeutic entity | NTE
    en
    Definition medicinal product that addresses an unmet patient need and is based on a known molecule, is formulated or used in a novel way, and has shorter development timelines and lower costs Reference "COM-Terminology Coordination, based on: Fereshteh Barei, Malcolm Ross. 'The refinement of the super generic concept: semantic challenge for product re-innovation?' (23.3.2023) GaBI Journal. Volume 4 | 2015 | Issue 1"
    nouvelle entité thérapeutique
    fr
    Definition médicament répondant à un besoin non satisfait des patients, aux coûts et aux délais de développement réduits, formulé ou employé d’une manière innovante à partir d’une molécule connue Reference "COM-FR, d'après le site GaBiJournal - Generics and Biosimilars Initiative Journal > The refinement of the super generic concept: semantic challenge for product re-innovation? (31.5.2023) Fereshteh Barei, Malcolm Ross, (2015), Volume 4, Issue 1 (uniquement en anglais)"
  12. SOCIAL QUESTIONS|health|medical science

    #651261

    IATE #3552418
    dáileog fhotheiripeach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    subtherapeutische Dosis
    de
    subtherapeutic dose | sub-therapeutic dose
    en
    Definition drug dose below the level necessary to produce a therapeutic effect Reference "COM-EN, based on: 'subtherapeutic'. Collins English Dictionary. http://www.collinsdictionary.com/dictionary/english/subtherapeutic [09.9.2015]"
    Comment "See also: subcurative dose [ IATE:3567405 ]"
    dose sous-thérapeutique
    fr
    Comment "Il faut distinguer la dose sous-thérapeutique (en-dessous de la dose qui entraîne un effet thérapeutique) du sous-dosage [ IATE:3565932 ] qui a malgré tout un effet thérapeutique, quoique insuffisant."
  13. SCIENCE|natural and applied sciences|life sciences|pharmacology

    #681972

    IATE #2251250
    aicme theiripeach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    therapeutic class | pharmacotherapeutic group | therapeutic category
    en
    Definition drugs grouped together by the pathology they are used to treat Reference "COM-Terminology Coordination, based on: Wikipedia > Drug class (13.2.2023)"
    Comment "Not to be confused with 'pharmacological class'."
    classe pharmacothérapeutique | classe thérapeutique
    fr
  14. SOCIAL QUESTIONS|social affairs|social problem

    #652447

    IATE #3557457
    pobal teiripeach Reference "Mental Health Commission: Annual Report 2006: http://www.mhcirl.ie/File/ARIrish_2006.pdf ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context Tá pleananna ar bun chun seirbhís fhóiréinseach na mban a leathnú Isteach sa limistéar atá á úsáid i láthair na huaire do chlár VEC agus gníomhaíochtaí teiripeacha trí spás a úsáid in aice le haonad na mban (Aonad A). Tá pobal teiripeach á phleanáil laisigh den aonad. Reference "Mental Health Commission: Annual Report 2006: http://www.mhcirl.ie/File/ARIrish_2006.pdf"
    Definition cur chuige cóireála i leith fadhbanna drugaí agus/nó fadhbanna eile a bhaineann úsáid as timpeallacht shóisialta shain-deartha nó suíomh cóireála cónaitheach ina mbaintear leas as an bpróiseas sóisialta agus grúpa chun athruithe sóisialta agus síceolaíochta a spreagadh Reference "an Lárionad Faireacháin Eorpach um Dhrugaí agus um Andúil i nDrugaí (EMCDDA), http://www.emcdda.europa.eu/ [23/01/2014]"
    therapeutische Gemeinschaft
    de
    Definition Therapieansatz für Drogenprobleme und/oder andere Probleme, der sich auf eine gezielt konzipierte soziale Umgebung oder Einrichtung zur stationären Behandlung stützt und bei dem der soziale und der Gruppenprozess genutzt wird, um soziale oder psychologische Veränderungen voranzutreiben Reference "EMCDDA: Europäischer Drogenbericht; http://www.emcdda.europa.eu/ [15/01/2014]"
    therapeutic community
    en
    Definition treatment approach for drug and /or other problems that uses a purposefully designed social environment or residential treatment setting in which the social and group process is harnessed to promote social and psychological change Reference "European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), http://www.emcdda.europa.eu/ [23/01/2014]"
    communauté thérapeutique
    fr
    Definition approche thérapeutique en matière de drogue et/ou pour d'autres problèmes qui utilise un environnement social spécialement conçu ou un lieu de traitement résidentiel dans lequel le processus social et collectif est exploité pour promouvoir les changements sociaux et psychologiques Reference "Observatoire européen des drogues et des toxicomanies (OEDT), http://www.emcdda.europa.eu/ [23/01/2014]"
  15. SOCIAL QUESTIONS|health|pharmaceutical industry

    #644909

    IATE #3521005
    éifeacht theiripeach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context ...níl aon éifeacht theiripeach ag an táirge nó níor sholáthair an t‑iarratasóir go leor fianaise i dtaobh na héifeachta sin maidir leis an spriocspeiceas' Reference "Togra le haghaidh Rialachán maidir le táirgí íocshláinte tréidliachta, CELEX:52014PC0558/GA"
    therapeutische Wirksamkeit | therapeutische Wirkung
    de
    Definition messbare akute oder verzögerte, vorübergehende oder endgültige Verbesserung des Gesundheitszustands oder Wohlbefindens aufgrund der Anwendung einer therapeutischen Maßnahme, die sich auf eine oder mehrere pharmakologische Eigenschaft(en) der Maßnahme (des Medikaments) zurückführen lässt Reference Council-DE in Anlehnung an FR
    Comment es wird zuwelen zwischen Wirkung (kurzfristig) und Wirksamkeit (langfristig) unterschieden
    therapeutic effect
    en
    Definition consequence of a medical treatment of any kind, the results of which are judged to be desirable and beneficial Reference "Wikipedia http://en.wikipedia.org/wiki/Therapeutic_effect [12.5.2010]"
    effet thérapeutique
    fr
    Definition amélioration mesurable, immédiate ou retardée, transitoire ou définitive, de l’état de santé ou du bien-être d’un sujet en rapport avec l’utilisation d’un médicament et, a priori, explicable par une ou plusieurs de ses propriétés pharmacologiques Reference "Site du ministère des Affaires sociales et de la Santé > Médicaments.gouv.fr > Glossaire > Effet thérapeutique, http://www.sante.gouv.fr/medicaments,1969.html [12.8.2014]"
  16. SOCIAL QUESTIONS|health|pharmaceutical industry

    #681678

    IATE #2232844
    éifeachtúlacht theiripeach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    therapeutic efficacy
    en
    Definition capacity of a medical product to produce an effect under ideal conditions Reference "COM-Terminology Coordination, based on: - Graziano Onder. 'EMA Workshop: Ensuring safe and effective medicines for an ageing population' (30.5.2023)- EMA. 'Efficacy' (30.5.2023)"
    Comment In contrast to 'effectiveness', which is the capacity of a treatment to produce a desired effect in practice.
    effet thérapeutique
    fr
  17. SOCIAL QUESTIONS|health|pharmaceutical industry

    #670019

    IATE #35093
    substaint ghníomhach Reference "Rialachán Cur Chun Feidhme (AE) 2021/1280 maidir le bearta i ndáil le dea-chleachtas dáileacháin do shubstaintí gníomhacha a úsáidtear mar ábhair thosaigh i dtáirgí íocshláinte tréidliachta i gcomhréir le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R1280/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context 'EUR 145200 i gcás ina n-áirítear trí shubstaint ghníomhacha agus/nó trí theaglaim de shubstaintí gníomhacha sa mheasúnú...' Reference "Rialachán (AE) Uimh. 658/2014 maidir le táillí is iníoctha leis an nGníomhaireacht Leigheasra Eorpach chun gníomhaíochtaí cógas-aireachais a dhéanamh i ndáil le táirgí íocshláinte lena n-úsáid ag an duine, CELEX:32014R0658/GA"
    substaint atá gníomhach ó thaobh na cógaseolaíochta de Reference "Rialachán (CE) Uimh. 470/2009 lena leagtar síos nósanna imeachta Comhphobail chun teorainneacha na n-iarmhar a bhunú do shubstaintí atá gníomhach ó thaobh na cógaseolaíochta de i mbia-ábhair de thionscnamh ainmhíoch, CELEX:32009R0470/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context 'Le Rialachán (CEE) Uimh. 2377/90 ón gComhairle an 26 Meitheamh 1990 lena leagtar síos nós imeachta Comhphobail chun teorainneacha na n-iarmhar a bhunú do shubstaintí atá gníomhach ó thaobh na cógaseolaíochta de i mbia-ábhair de thionscnamh ainmhíoch (3), tugadh isteach nósanna imeachta Comhphobail chun sábháilteacht iarmhair na substaintí atá gníomhach ó thaobh na cógaseolaíochta de a mheas i gcomhréir le ceanglais sábháilteachta an bhia don duine. Ní fhéadfar substaint atá gníomhach ó thaobh na cógaseolaíochta de a úsáid i mbia-ainmhithe ach má mheasúnaítear go fabhrach í.' Reference "Rialachán (CE) Uimh. 470/2009 lena leagtar síos nósanna imeachta Comhphobail chun teorainneacha na n-iarmhar a bhunú do shubstaintí atá gníomhach ó thaobh na cógaseolaíochta de i mbia-ábhair de thionscnamh ainmhíoch, agus lena n-aisghairtear Rialachán (CEE) Uimh. 2377/90 ón gComhairle agus lena leasaítear Treoir 2001/82/CE ó Pharlaimint na hEorpa agus ón gComhairle agus Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32009R0470/GA"
    eintiteas teiripeach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Cé is moite de roinnt eisceachtaí, tá tairbhe chliniciúil theoranta ag na hantaibheathaigh nua-fhormheasta sa bhreis ar na cóireálacha atá ann cheana, ós rud é go dtagann os cionn 80 % díobh ó aicmí atá ann cheana ina bhfuil sásraí frithsheasmhachta dea-bhunaithe agus ina bhfuil sé beartaithe go dtiocfaidh frithsheasmhacht chun cinn go tapa. Faoi láthair tá 43 antaibheathach agus comhcheangal le heintiteas teiripeach nua á bhforbairt.' Reference "Togra le haghaidh Moladh maidir le dlús a chur le gníomhaíochtaí an Aontais chun an frithsheasmhacht in aghaidh ábhair fhrithmhiocróbacha a chomhrac trí chur chuige na hAon Sláinte Amháin, CELEX:52023DC0191/GA"
    Wirkstoff | wirksamer Bestandteil | arzneilich wirksamer Bestandteil | pharmakologisch wirksamer Stoff | Arzneistoff
    de
    Definition Stoff, der bei der Herstellung eines Arzneimittels zu einem seiner pharmakologisch wirksamen Bestandteile wird Reference "Council-DE, vgl. Verordnung (EU) 2019/6 über Tierarzneimittel, Art. 4 Abs. 3"
    Comment """Anders formuliert sind Wirkstoffe also diejenigen Bestandteile eines Arzneimittels, die für seine Wirksamkeit verantwortlich sind."""
    active substance | pharmacologically active substance | therapeutic entity | active ingredient | therapeutic substance
    en
    Definition substance responsible for the pharmacological activity of a medicinal product Reference "COM-Terminology Coordination, based on: 'active substance' (26.7.2023). EMA. Glossary"
    Comment "The quantity of the active substance should be expressed per dosage unit (for metered dose inhalation products, per delivered dose and/or per metered dose), per unit volume, or per unit of weight and should be related to the declaration of strength. Quantity should be expressed in internationally recognised standard term which could be complemented with another term if more meaningful to healthcare professionals."
    substance active
    fr
  18. SOCIAL QUESTIONS|health|pharmaceutical industry

    #619178

    IATE #1105803
    innéacs teiripeach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    therapeutische Breite
    de
    therapeutic index | TI
    en
    Definition ratio that compares the blood concentration at which a drug becomes toxic and the concentration at which the drug is effective Reference "AIDSinfo. Education materials. Glossary. Therapeutic Index, http://aidsinfo.nih.gov/education-materials/glossary/865/therapeutic-index [9.12.2013]"
    Comment The larger the therapeutic index (TI), the safer the drug is.
    indice thérapeutique | index thérapeutique | plage thérapeutique
    fr
    Definition rapport entre la dose curative et la dose toxique d'un médicament Reference Le Petit Robert de la langue française > indice [21.1.2015]
  19. SOCIAL QUESTIONS|health|pharmaceutical industry

    #679962

    IATE #1529049
    tásc teiripeach Reference "An Ghníomhaireacht Leigheasra Eorpach. Achoimrí ar shaintréithe táirgí. Product-information templates - Human | European Medicines Agency (europa.eu)"
    ga
    Context 1. SONRAÍ CLINICIÚLA 1.1 Tásca teiripeacha Reference "An Ghníomhaireacht Leigheasra Eorpach. Achoimrí ar shaintréithe táirgí. Product-information templates - Human | European Medicines Agency (europa.eu)"
    tásc Reference "An Ghníomhaireacht Leigheasra Eorpach. Achoimrí ar shaintréithe táirgí. Product-information templates - Human | European Medicines Agency (europa.eu)"
    ga
    Context <Chuir an Ghníomhaireacht Leigheasra Eorpach ar leataobh an oibleagáid torthaí staidéir le<{Ainm (cumtha)}> [nó le haghaidh táirgí cineálacha: <an táirge íocshláinte ina bhfuil {ainm na substainte gníomhaí/na substaintí gníomhacha}>] a chur isteach i ngach fothacar den daonra péidiatrach in {coinníoll de réir mar atá i gcinneadh an phlean imscrúdaithe phéidiatraigh (PIP), don tásc tugtha} (féach roinn 4.2 faoi choinne faisnéise ar úsáid phéidiatrach).> Reference "An Ghníomhaireacht Leigheasra Eorpach. Achoimrí ar shaintréithe táirgí. Product-information templates - Human | European Medicines Agency (europa.eu), Iarscríbhinn I: Achoimre ar Shaintréithe an Táirge"
    therapeutische Indikation | Indikation | Heilanzeige | Anwendungsgebiet
    de
    Definition bei einer bestimmten Krankheit angezeigte Anwendung bestimmter Heilmittel oder Heilverfahren Reference "Duden > Heilanzeige (17.4.2024)"
    therapeutic indication | indication
    en
    Definition "EMA (European Medicines Agency). Product information templates (18.3.2024) > 'Quality Review of Documents human product-information template version 10.4' (18.3.2024)"
    Definition any of the conditions for which a particular drug treatment may be prescribed, as defined by its licence Reference "'indication' (20.3.2024), Concise Medical Dictionary (8 ed.), Oxford University Press (OUP), 2010."
    Comment any of the conditions for which a particular drug treatment may be prescribed, as defined by its licence
  20. SOCIAL QUESTIONS|health|pharmaceutical industry

    #687582

    IATE #3633871
    nuálaíocht theiripeach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Nuair a chuirtear isteach iarratas ar údarú margaíochta i dtaca le táirgí íocshláinte tréidliachta ar díol mór spéise iad, go háirithe ó thaobh sláinte ainmhithe agus nuálaíocht theiripeach de, féadfaidh an t-iarratasóir nós imeachta maidir le measúnú brostaithe a iarraidh.' Reference "Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA"
    therapeutic innovation
    en