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12 results in 6 documents

  1. #2012895

    Frithvíreasaigh le haghaidh úsáid chórasach: QJ05.

    Antivirals for systemic use: QJ05.

    Commission Delegated Regulation (EU) 2021/578 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council with regard to requirements for the collection of data on the volume of sales and on the use of antimicrobial medicinal products in animals (Text with EEA relevance)

  2. #2012910

    Frithvíreasaigh le haghaidh úsáid chórasach: QJ05, J05.

    Antivirals for systemic use: QJ05, J05.

    Commission Delegated Regulation (EU) 2021/578 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council with regard to requirements for the collection of data on the volume of sales and on the use of antimicrobial medicinal products in animals (Text with EEA relevance)

  3. #2480887

    Frithvíreasaigh

    Antivirals

    Commission Implementing Regulation (EU) 2022/1255 of 19 July 2022 designating antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans, in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)

  4. #2637528

    Go háirithe, tá ról tábhachtach ag frithvíreasaigh agus ag antasubstaintí monaclóineacha frithvíreasacha chun cóireáil a chur ar othair a bhfuil COVID-19 orthu.

    In particular, antivirals and antiviral monoclonal antibodies play an important part in treating COVID-19 patients.

    COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS EU response to COVID-19: preparing for autumn and winter 2023

  5. #1733785

    ciallaíonn “ábhar frithmhiocróbach” aon substaint a bhfuil gníomhaíocht dhíreach aici ar mhiocrorgánaigh a úsáidtear chun cóireáil nó cosc a chur ar ionfhabhtuithe nó ar ghalair thógálacha, lena n-áirítear antaibheathaigh, frithvíreasaigh, frithfhungasaigh agus frithphrotzoaigh;

    ‘antimicrobial’ means any substance with a direct action on micro-organisms used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals, antifungals and anti-protozoals;

    Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)

  6. #2637529

    Go dtí seo, údaraíodh ocht dtáirge theiripeacha COVID-19 i gcatagóirí éagsúla, lena n‑áirítear sé tháirge frithvíreas, agus tugann gach ceann acu aghaidh ar chéim agus ar dhéine éagsúil den ghalar.

    To date, eight COVID-19 therapeutics of different categories have been authorised, including six antivirals, addressing different stages and severity of the disease.

    COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS EU response to COVID-19: preparing for autumn and winter 2023

  7. #2012730

    Úsáidfidh na Ballstáit agus an Ghníomhaireacht córas aicmithe tréidliachta Ceimiceach Teiripeach Anatamaíoch (ATCvet) agus an córas aicmithe le haghaidh Ceimiceáin Theiripigh Anatamaíocha (ATC), de réir mar is infheidhme, chun substaintí a bhfuil éifeacht antaibheathach acu a shainaithint, mar aon le frithfhungasaigh, frithvíreasaigh agus frithphrótasólaigh atá ábhartha maidir le bailiú sonraí.

    Member States and the Agency shall use the Anatomical Therapeutic Chemical veterinary (ATCvet) classification system and the Anatomical Therapeutic Chemical (ATC) classification system, as applicable, to identify substances with antibiotic effect, antifungals, antivirals and antiprotozoals of relevance for the collection of data.

    Commission Delegated Regulation (EU) 2021/578 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council with regard to requirements for the collection of data on the volume of sales and on the use of antimicrobial medicinal products in animals (Text with EEA relevance)

  8. #2049801

    Baineann na ceanglais maidir le sonraí a thuairiscítear sa phointe seo le substaintí frithbhaictéaracha agus d’fhéadfaí nach mbeidís infheidhme go hiomlán maidir le cineálacha eile oibreáin fhrithmhiocróbaigh (eadhon drugaí frithvíreasacha, drugaí frithfhungasacha agus drugaí frithphrótasólacha) ach féadfar na ceanglais a leanúint, i bprionsabal, i gcás inarb infheidhme mar sin féin.

    The data requirements described in this point are related to antibacterial substances and may not be fully applicable to other types of antimicrobial (namely antivirals, antifungals and antiprotozoals) although, in principle, the requirements may be followed, where applicable.

    Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)

  9. #2050103

    Baineann na ceanglais maidir le sonraí a luaitear sa phointe seo le substaintí frithbhaictéaracha agus d’fhéadfaí nach mbeidís infheidhme maidir le cineálacha eile oibreáin fhrithmhiocróbaigh (eadhon drugaí frithvíreasacha, drugaí frithfhungasacha agus drugaí frithphrótasólacha); i gcás substaintí nach drugaí frithbhaictéaracha iad dá bhfuil frithsheasmhacht fhrithmhiocróbach seanbhunaithe, féadfar na ceanglais chéanna a leanúint, i gcás inarb infheidhme.

    The data requirements mentioned in this point are related to antibacterial substances and may not be applicable to other types of antimicrobial (namely antivirals, antifungals and antiprotozoals); for substances other than antibacterial for which the existence of antimicrobial resistance is well established, the same requirements may be followed, where applicable.

    Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)

  10. #2480839

    De bhun chomhairle na Gníomhaireachta, chomhlíon roinnt antaibheathach, roinnt frithvíreas agus druga frithphrótasólach amháin na critéir arna mbunú faoi Rialachán Tarmligthe (AE) 2021/1760 agus ba cheart, dá bhrí sin, iad a fhorchoimeád chun ionfhabhtuithe áirithe i ndaoine a chóireáil.

    Pursuant to the Agency’s advice, several antibiotics, several antivirals and one antiprotozoal fulfilled the criteria established under Delegated Regulation (EU) 2021/1760 and should therefore be reserved for the treatment of certain infections in humans.

    Commission Implementing Regulation (EU) 2022/1255 of 19 July 2022 designating antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans, in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)

  11. #2570966

    Foráiltear leis an gComhaontú sin maidir le Soláthar Comhpháirteach do shásra deonach do thíortha rannpháirteacha agus d’institiúidí an Aontais chun frithbhearta leighis a cheannach go comhpháirteach le haghaidh catagóirí éagsúla bagairtí trasteorann ar an tsláinte, lena n-áirítear vacsaíní, frithvíreasaigh agus cóireálacha eile.

    That Joint Procurement Agreement provides for a voluntary mechanism for participating countries and the Union institutions to jointly purchase medical countermeasures for different categories of cross-border threats to health including vaccines, antivirals and other treatments.

    Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (Text with EEA relevance)

  12. #2637564

    Ar an gcaoi chéanna, agus i gcomhréir leis an hipitéis atá ag teacht chun cinn go bhféadfadh taiscumair leanúnacha víris a bheith ar cheann de na cúiseanna leis an riocht iar-COVID, d’fhéadfaí táirgí teiripeacha a úsáidtear chun COVID-19 a chóireáil (amhail frithvíreasaigh) a thástáil freisin mar chóireáil fhéideartha le haghaidh an reachta iar-COVID.

    Equally, and in keeping with the emerging hypothesis that persistent viral reservoirs may be one cause of post-COVID condition, therapeutics used to treat COVID-19 (such as antivirals) could also be tested as a potential treatment for post-COVID condition.

    COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS EU response to COVID-19: preparing for autumn and winter 2023