Gaois

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64 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry
    táirge íocshláinte Reference Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:32014R0536/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Aithneoidh an Ghníomhaireacht torthaí an mheasúnaithe sin ina meastóireacht ar an táirge íocshláinte lena mbaineann.' Reference Rialachán (CE) Uimh. 1394/2007 maidir le táirgí íocshláinte ardteiripe agus lena leasaítear Treoir 2001/83/CE agus Rialachán (CE) Uimh. 726/2004, CELEX:32007R1394/GA
    táirge cógaisíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    cógas leighis Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Is iad acmhainní géiniteacha linn na ngéinte i speicis nádúrtha agus i speicis cheansaithe nó shaothraithe araon agus tá ról suntasach acu, agus ról atá ag méadú, i roinnt mhaith earnálacha eacnamaíocha, lena n-áirítear táirgeadh bia, foraoiseacht agus forbairt cógas leighis, cosmaidí agus foinsí bithbhunaithe fuinnimh.' Reference Rialachán (AE) Uimh. 511/2014 i ndáil le bearta comhlíonta d’úsáideoirí ó Phrótacal Nagoya maidir le Rochtain ar Acmhainní Géiniteacha agus Comhroinnt Chothrom agus Chothromasach na dTairbhí a eascraíonn as a nÚsáid san Aontas, CELEX:32014R0511/GA
    Medikament | Arzneimittel
    de
    Definition Stoff oder Stoffzusammensetzung, der/die als Mittel zur Heilung oder zur Verhütung menschlicher Krankheiten bezeichnet wird Reference Richtlinie 2001/83/EG des Europäischen Parlaments und des Rates vom 6. November 2001 zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel, Art.1 Nr.2 CELEX:32001L0083/DE
    Comment Alle Stoffe oder Stoffzusammensetzungen, die dazu bestimmt sind, im oder am menschlichen Körper zur Erstellung einer ärztlichen Diagnose oder zur Wiederherstellung, Besserung oder Beeinflussung der menschlichen physiologischen Funktionen angewandt zu werden, gelten ebenfalls als Arzneimittel
    medicinal products | drug | medicine | pharmaceutical product | medicinal product | pharmaceutical drug | drug product | pharmaceutical
    en
    Definition any substance or combination of substances presented as having properties for treating or preventing disease in human beings, or 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 Reference Directive 2001/83/EC on the Community code relating to medicinal products for human use, Article 1(2) (consolidated version)
    Comment For veterinary medicinal product, see IATE:1225197 For pharmaceutical product in the broad sense used in EU legislation, see IATE:779919
    médicament
    fr
    Definition toute substance ou composition présentée comme possédant des propriétés curatives ou préventives à l'égard des maladies humaines Reference Directive 2001/83/CE du Parlement européen et du Conseil instituant un code communautaire relatif aux médicaments à usage humain, CELEX:32001L0083/FR [12.2.2018]
    Comment Toute substance ou composition pouvant être administrée à l'homme en vue d'établir un diagnostic médical ou de restaurer, corriger ou modifier des fonctions physiologiques chez l'homme est également considérée comme médicament. (Source: ibid.)
  2. INTERNATIONAL ORGANISATIONS|extra-European organisations|African organisation|African Union · SOCIAL QUESTIONS|health|health policy
    an Ghníomhaireacht Leigheasra Afracach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    African Medicines Agency
    en
    Definition entity established by the African Union Treaty for the Establishment of the African Medicines Agency with the objective to enhance capacity of the Parties of the treaty to regulate medical products in order to improve access to quality, safe and efficacious medical products on the African continent Reference COM-Terminology Coordination, based on:Treaty for the Establishment of the African Medicines Agency (14.9.2021). February 11, 2019.
    Agence africaine du médicament | AMA
    fr
    Definition agence spécialisée de l'Union africaine, ayant pour objectif d'améliorer les capactiés des États parties et des communautés économies régionales d'Afrique à réglementer les produits médicaux en vue d'améliorer l'accès à des produits médicaux de qualité, sans risque et efficaces sur le continent africain Reference Conseil-FR, d'après site de l'Union africaine, Accueil > Traités > Traité portant création de l'Agence africaine du médicament (3.2.2022)
    Comment Adpotion 11.2.2019, Addis-Abeba (Ethiopie)
  3. SOCIAL QUESTIONS|health|pharmaceutical industry
    capsúl folamh, oiriúnach d'úsáid cógaisíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Oblatenkapsel für Arzneiwaren
    de
    Definition aus gebackenem Stärke- oder Mehlteig hergestellte flache Kapsel, deren Ränder aufgeworfen sind, damit sie paarweise ein Behältnis bilden kann Reference Zolltarif
    cachet | empty cachet of a kind suitable for pharmaceutical use
    en
    Definition flat capsule containing a drug that has an unpleasant taste Reference "cachet n." A Dictionary of Nursing. Oxford University Press (OUP), 2008. Oxford Reference Online. OUP. DGT. http://www.oxfordreference.com/views/ENTRY.html?subview=Main&entry=t62.e1269 [21.7.2010]
    cachet pour médicament
    fr
    Definition pâte d'amidon ou de farine cuite, consistant en cupules à bords relevés de manière à s'emboîter Reference Tarif douanier
  4. INTERNATIONAL ORGANISATIONS|European organisations|European organisation|Council of Europe · SOCIAL QUESTIONS|health|health policy|organisation of health care|pharmacy
    an Stiúrthóireacht Eorpach um Cháilíocht Leigheasra agus Cúraim Sláinte Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    EDQM | Europäische Direktion für die Qualität von Medikamenten
    de
    EDQM | European Directorate for the Quality of Medicines & HealthCare
    en
    Definition key European organisation involved in harmonisation & co-ordination of standardisation, regulation & quality control of medicines, blood transfusion, organ transplantation, pharmaceuticals and pharmaceutical care Reference European Directorate for the Quality of Medicines & HealthCare (EDQM), http://www.edqm.eu/site/Homepage-628.html (13.11.2009)
    Direction Européenne de la Qualité du Médicament et Soins de Santé | DEQM
    fr
    Definition "En dehors de la surveillance systématique de la conformité des substances, la Direction européenne pour la qualité du médicament met au point, de façon régulière, de nouveaux essais destinés à déceler les falsifications." Reference < http://www.coe.int/t/f/communication%5Fet%5Frecherche/presse/dossiers%5Fth%E9matiques/L%27Europe%5Fdu%5Fm%E9dicament/ >
    Comment MISC: créée en 1995; site web (EN uniquement): http://www.pheur.org/
  5. SOCIAL QUESTIONS|health|pharmaceutical industry
    táirge íocshláinte luibhe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    pflanzliches Arzneimittel
    de
    Definition 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 Reference 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 medicine | herbal medicinal product
    en
    Definition any 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 Reference Article 1(30) of Directive 2001/83/EC on the Community code relating to medicinal products for human use, CELEX:02001L0083/EN , as added by Article 1(1) of Directive 2004/24/EC, CELEX:32004L0024/EN
    médicament à base de plantes
    fr
  6. SOCIAL QUESTIONS|health|pharmaceutical industry
    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 index thérapeutique étroit | médicaments à marge thérapeutique étroite | médicament à indice thérapeutique étroit | médicament à index thérapeutique faible | médicament à marge thérapeutique étroite | 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").
  7. SOCIAL QUESTIONS|health|health policy · SOCIAL QUESTIONS|health|pharmaceutical industry
    táirge íocshláinte lena úsáid ag an duine Reference 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
    Context '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.' Reference 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
    Definition 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 Reference 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
    Comment See also:- IATE:773210 "veterinary medicinal product; medicinal product for veterinary use" - IATE:793544 "medicinal product"
    médicament à usage humain
    fr
  8. SOCIAL QUESTIONS|health|pharmaceutical industry
    táirge íocshláinte péidiatraiceach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    pädiatrische Arzneimittel | Kinderarzneimittel | Pharmazeutika für Kinder
    de
    paediatric medicine | paediatric drug | medicinal product for use in the paediatric population | paediatric medicinal product
    en
    Definition medicinal product used to treat persons aged 0-18 Reference COM-Term. Coord., based on:Regulation (EC) No 1901/2006 on medicinal products for paediatric use, CELEX:32006R1901/EN
    médicament à usage pédiatrique | médicament pédiatrique
    fr
    Definition médicament destiné aux enfants Reference Organisation mondiale de la santé, Médicaments: médicaments destinés aux enfants, http://www.who.int/mediacentre/factsheets/fs341/fr/ [12.12.2013]
  9. SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product
    táirge míochaine tréidliachta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context '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.' Reference 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
    táirge íocshláinte tréidliachta Reference 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
    Context 'Luafar san iarratas ar údarú margaíochta láraithe le haghaidh táirge íocshláinte tréidliachta ainm amháin don táirge íocshláinte tréidliachta a úsáidfear ar fud an Aontais.' Reference Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA
    Tierarzneimittel
    de
    Definition 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 Reference vgl. Legaldefinition in Richtlinie 2001/82/EG zur Schaffung eines Gemeinschaftskodexes für Tierarzneimittel, ABl. L_311/2001 CELEX:02001L0082-20090807/DE
    VMPs | VMP | veterinary medicinal product | veterinary drug | veterinary medicine
    en
    Definition 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 Reference Regulation (EU) 2019/6 on veterinary medicinal products
    médicament à usage vétérinaire | médicament vétérinaire
    fr
    Definition toute substance ou composition présentée comme possédant des propriétés curatives ou préventives à l'égard des maladies animales Reference directive 2001/82/CE, art.1.2, JOCE L311/2001
  10. SOCIAL QUESTIONS|health|pharmaceutical industry
    druga ginmhillteach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Ambloticum | Pellentium | Abortifikans | Abortizid | abortiv | Ektrotikum | abortivus | Abortivum:Abortifaziens | Ekbolikum
    de
    Definition Mittel, das wegen seiner wehenerzeug.,frucht-u. kindsmutterschaedig. Wirkung zur Erzielung eines kriminellen Abortes eingenommen wird.I.w.S.auch die aeusserl. angewandten Abtreibungsmethoden Reference Reallex Med
    abortive | abortifacient | abortifacient drug
    en
    Definition a drug that induces abortion Reference Scientific American, December 2000
    médicament abortif | abortif | substance abortive
    fr
    Definition médicament destiné à provoquer l'avortement Reference Reimen
  11. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product|medicament
    antaithéachtach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Antikoagulationsmittel | Antikoagulator | Antikoagulans | Antikoagulanzien | Gerinnungshemmer | Antikoagulantium | Antithrombotikum
    de
    Definition Medikament, das die Blutgerinnung (Hämostase) hemmt Reference DocCheckFlexikon, s. v. „Antikoagulans“, http://flexikon.doccheck.com/de/Antikoagulans (30.9.2017)
    anticoagulant drug | anticoagulant | anti-coagulant
    en
    Definition substance that prevents or reduces coagulation of blood, prolonging the clotting time [ IATE:1498931 ] Reference Wikipedia. Anticoagulant, https://en.wikipedia.org/wiki/Anticoagulant [17.12.2018]
    médicament anti-coagulant | anticoagulant
    fr
    Definition substance qui s'oppose à la coagulation du sang Reference CILF
  12. SCIENCE|natural and applied sciences|life sciences|pharmacology · SOCIAL QUESTIONS|health|pharmaceutical industry
    oibreán antai-ionfhabhtaíoch Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    antai-ionfhabhtaíoch Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Mittel gegen Infektionen | antiinfektiöses Mittel | antiinfektiös
    de
    anti-infectious agent | anti-infective | anti-infective agent | antiinfective
    en
    Definition medicinal product used to prevent or treat infections Reference COM-Terminology Coordination, based on: Pfizer. 'About Anti-Infectives' (25.2.2021)
    Comment They include antibacterials, antivirals, antifungals (and antimycotics) and antiparasitic medications
    anti-infectieux | médicament anti-infectieux
    fr
    Definition qui combat l'infection Reference BIAM,Petit lexique de termes médicaux,1998
  13. SOCIAL QUESTIONS|health|pharmaceutical industry
    oibreán frithmhiocróbach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Ciallaíonn “frithsheasmhacht in aghaidh ábhair fhrithmhiocróbacha” cumas miocrorgánach teacht slán nó fás áit a bhfuil tiúchan oibreán frithmhiocróbach ar gnách gur leor é chun miocrorgánaigh den speiceas céanna a chosc nó a mharú...' Reference Rialachán (AE) 2019/6 maidir le táirgí íocshláinte tréidliachta agus lena n-aisghairtear Treoir 2001/82/CE, CELEX:32019R0006/GA
    Stoff mit antimikrobieller Wirkung | antimikrobielles Mittel | antimikrobieller Stoff | mikrobenabweisender Stoff | antimikrobieller Wirkstoff | Antimikrobenmittel | antimikrobiell wirkender Stoff
    de
    Definition synthetisch oder auf natürlichem Wege durch Bakterien, Pilze oder Pflanzen erzeugte Biozide, die zur Abtötung von Mikroorganismen - Bakterien, Viren, Pilze und Parasiten, insbesondere Protozoen - oder zur Hemmung ihres Wachstums eingesetzt werden Reference Empfehlung zur umsichtigen Verwendung antimikrobieller Mittel in der Humanmedizin, Erw.1 (ABl. L_34/2002, S.13) CELEX:32002H0077/DE
    Comment umfasst neben Antibiotika IATE:1098823 , Virustatika, Antimykotika, Antiparasitika aber auch Desinfektionsmittel; XREF: Antibiotikum IATE:1098823 ; Antibiotika-Resistenz IATE:1073649 ; Antimikrobielle Resistenz IATE:912591 ; DIV: RSZ, 7.10.09
    antimicrobial substance | antimicrobial medicine | antimicrobial | antimicrobial medicinal product | antimicrobial agent | antimicrobial drug
    en
    Definition any naturally occurring, semi-synthetic or synthetic substance that exhibits antimicrobial activity (kills or inhibits the growth of micro-organisms) and/or the final medicinal product containing such an active substance Reference Directive 2005/25/EC amending Annex VI to Directive 91/414/EEC as regards plant protection products containing micro-organisms
    Comment Includes antibiotics, antivirals, antifungals, anticoccidials and antiprotozoals.
    antimicrobien | substance antimicrobienne | agent anti-microbien | médicament antimicrobien | agent antimicrobien
    fr
    Definition toute substance produite de manière synthétique ou naturelle par des bactéries, des champignons ou des plantes, utilisée pour détruire ou empêcher la croissance de micro-organismes tels que les bactéries, les virus et les champignons, ainsi que des parasites, en particulier les protozoaires Reference Communication de la Commission sur une stratégie communautaire de lutte contre la résistance antimicrobienne CELEX:52001DC0333/FR
  14. SOCIAL QUESTIONS|health|pharmaceutical industry
    cógas frith-aisvíreasach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    antiretroviral | antiretrovirales Medikament
    de
    Definition gegen das Retrovirus IATE:874331 gerichtet; Arzneimittel, das die Vermehrung von Retroviren hemmt Reference Joachim-Kuhlmann-AIDS-Stiftung http://www.jk-aids-stiftung.de/archiv/woerterbuch_ac.html (27.8.2010)
    Comment UPD: aih, 9.8.07
    antiretroviral drug | ARV | antiretroviral medicine | anti-retroviral | antiretroviral agent | antiretroviral
    en
    Definition agent or process effective against a retrovirus Reference MedicineNet.com > Antiretroviral, http://www.medterms.com/script/main/art.asp?articlekey=23516 [29.9.2010]
    Comment For example, a drug to treat HIV.
    antirétroviral | agent anti-rétroviral | médicament anti-rétroviral
    fr
    Definition antiviral agissant sur les virus à ARN en inhibant leur reverse-transcriptase (pour la première famille d'antirétroviraux):AZT, ddI, ddC, d4T,3TC ou leur protéase: Ritonavir (c),Indinavir (c),Saquinavir (c) Reference Act Up-Paris,Gloss.sida,janvier 1998
  15. SOCIAL QUESTIONS|health|pharmaceutical industry
    táirge íocshláinte cúntach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Hilfspräparat
    de
    auxiliary medicinal product | auxiliary medicinal products
    en
    Definition medicinal product used in the context of a clinical trial, but not as an investigational medicinal product Reference 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
    Comment 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
    Definition médicament utilisé dans le contexte d'un essai clinique, mais non comme médicament expérimental Reference COM-Document interne: SANCO-2012-80155-00-04Règlement relatif aux essais cliniques de médicaments à usage humain
  16. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product
    táirge íocshláinte bitheolaíoch Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Biologika | Biologikum | biologisches Arzneimittel | Biopharmakon
    de
    Definition Arzneimittel, dessen Wirkstoff ein biologischer Stoff ist Reference Richtlinie 2003/63/EG der Kommissionzur Änderung der Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel
    biopharmaceutical | biomedicine | biologic | biological medicinal product
    en
    Definition product, the active substance of which is a biological substance Reference CELEX:32003L0063/EN Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
    médicament biologique | biomédicament
    fr
    Definition produit dont la substance active est une substance biologique Reference Directive 2003/63/CE de la Commission, CELEX:32003L0063/fr
  17. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product
    leigheas bithchosúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    biologics | products | biosimilar | biosimilars | similar biological medicinal product | subsequent-entry biologic | biosimilar medicinal product | similar biological | biosimilar medicine | follow-on protein product | biogeneric
    en
    Definition biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’) Reference COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products
    Comment Unlike the small molecules of classical medicines, which are ‘chemically’ synthesised, the much more complex biosimilars are extracted or synthesised from biological sources such as blood or tissues, and for this reason cannot be fully identical to their reference products.
    médicament biologique similaire | biosimilaire | biogénérique
    fr
  18. LAW|criminal law · SOCIAL QUESTIONS|health · SOCIAL QUESTIONS|social affairs
    druga dearthóra Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Designerdroge | Clubdroge | Designer-Droge | Partydroge
    de
    Definition psychoaktive Substanz IATE:758311 , die durch Veränderung ihrer Molekularstruktur eine gegenüber der (bekannten und verbotenen) Stammsubstanz optimierte Wirkung erzielen soll und mit dem Ziel hergestellt wird, betäubungsmittelrechtliche Regelungen zu umgehen Reference Vgl. Stellungn. WSA RL-Vorschlag für zur Änderung der RL 92/109/EWG des Rates über die Herstellung und das Inverkehrbringen bestimmter Stoffe, die zur unerlaubten Herstellung von Suchtstoffen und psychotropen Stoffen verwendet werden, ABl. C_214/1998, S.11 CELEX:51998AC0623/DE
    Comment Designerdrogen sind meist Derivate bekannter Drogen (wobei die Wirkung des verbotenen Ausgangsstoffes gezielt gesteigert wird), z.T. aber auch völlig neue Zusammensetzungen;DIV: aka 7.12.10
    designer drug
    en
    Definition a substance whose molecular structure has been modified in order to optimise its effect on the one hand, and in order to by-pass laws and regulations governing the control of substances on the other hand Reference Drugs-rehabs.org > Drug facts, http://www.drug-rehabs.org/Connecticut-Meriden-drug-rehab-treatment.htm [31.3.2013]
    Comment NB: Strictly speaking, once designer drugs have been outlawed by the competent authorities they are called controlled substances. However, in practice there is some blurring, as illegal drugs such as ecstasy are still known as designer drugs.Sometimes used synonymously with 'legal high' [ IATE:3528327 ], although, strictly speaking, legal highs also include natural drugs such as 'Salvia divinorum' or even pond cleaner [Council-EN, 13.12.2010].See also 'new psychoactive substance' [ IATE:3529087 ] and 'new synthetic drug' [ IATE:901738 ].
    drogue de confection | designer drug | médicament bricolé
    fr
    Definition Variante chimique (analogue) d'une substance placée sous contrôle [qui] produit un état d'euphorie, mais du fait d'une modification infime de la structure chimique de la molécule «mère», [...] n'entre pas dans les catégories visées par la législation sur les stupéfiants. Reference D'après: TERMIUM Plus ®, Travaux publics et Services gouvernementaux Canada, http://www.btb.termiumplus.gc.ca/tpv2alpha/alpha-fra.html?lang=fra&i=&index=alt&__index=alt&srchtxt=designer+drug&comencsrch.x=0&comencsrch.y=0
    Comment Ce type de drogue fait partie des hallucinogènes, lesquels constituent une sous-catégorie des drogues de synthèse [ IATE:895318 ]. (cf. Caballero F. et Bisiou Y., "Droit de la drogue", éd. Dalloz, Paris, 2000)