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 »

2 thoradh

  1. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product
    táirge íocshláinte bitheolaíoch Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs 'Ní bheidh an t-athrú infheidhme maidir le táirge íocshláinte bitheolaíoch ná táirge íocshláinte imdhíoneolaíoch.' Tagairt "Rialachán Cur Chun Feidhme (AE) 2023/997 lena leasaítear Rialachán Cur Chun Feidhme (AE) 2021/17 lena mbunaítear liosta modhnuithe nach n-éilíonn measúnú i gcomhréir le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32023R0997/GA"
    bithchógas Tagairt "Comhairle-GA, bunaithe ar 'bithchógasaíocht' (téarma a chuireann síos ar an mbrainse eolaíochta seachas an táirge féin) in Dearbhú Versailles Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    biologisches Arzneimittel | Biologikum | Biologika | Biopharmakon
    de
    Sainmhíniú "Arzneimittel, dessen Wirkstoff ein biologischer Stoff ist" Tagairt "Richtlinie 2003/63/EG der Kommissionzur Änderung der Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel"
    biological medicinal product | biologic | biomedicine | biopharmaceutical
    en
    Sainmhíniú "product, the active substance of which is a biological substance" Tagairt "Directive 2001/83/EC on the Community code relating to medicinal products for human use"
    Nóta medicinal product, the active substance of which is produced by or extracted from a biological source and which due to its complexity, its characterisation and the determination of its quality may require a combination of physico-chemical-biological testing, together with its control strategy
    médicament biologique | biomédicament
    fr
    Sainmhíniú produit dont la substance active est une substance biologique Tagairt "Directive 2003/63/CE de la Commission, CELEX:32003L0063/fr"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product
    leigheas bithchosúil Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    biosimilar medicinal product | biosimilar | similar biological medicinal product | similar biological | biosimilar medicine | biogeneric
    en
    Sainmhíniú biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’) Tagairt "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"
    Nóta 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.
    biosimilaire | biogénérique | médicament biologique similaire
    fr