#1734637
níl aon tásca teiripeacha le feiceáil ar a lipéadú ná ar an bhfaisnéis a bhaineann leis.
it has no therapeutic indication appearing on its labelling or in any information relating thereto.
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#2050450
Soláthrófar sonraí breise ar an tásc teiripeach nua, mar aon le tástálacha iomchuí ar an tsábháilteacht agus ar iarmhair agus na sonraí réamhchliniciúla agus cliniciúla, agus sa chás sin ní féidir iarratais a dhéanamh bunaithe ar Airteagal 21.
Additional data on the new therapeutic indication, together with appropriate safety and residue tests and preclinical and clinical data shall be provided and, in such a case, applications based on Article 21 is not possible.
#2187391
Chun ardchaighdeán na measúnuithe cliniciúla comhpháirteacha a ráthú, glacadh forleathan a áirithiú agus comhthiomsú saineolais agus acmhainní ar fud údaráis agus comhlachtaí náisiúnta HTA a chumasú, is iomchuí cur chuige céim ar chéim a leanúint, ag tosú le líon beag táirgí íocshláinte a measúnaíodh go comhpháirteach agus, ag tráth níos déanaí amháin, a cheangal go ndéanfar measúnuithe cliniciúla comhpháirteacha ar tháirgí íocshláinte eile atá faoi réir an nós imeachta údarúcháin láraithe margaíochta dá bhforáiltear faoi Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle, agus i gcás ina n-údarófar na táirgí íocshláinte sin ina dhiaidh sin le haghaidh tásc teiripeach nua.
In order to guarantee the highest quality of joint clinical assessments, ensure a wide acceptance and enable pooling of expertise and resources across national HTA authorities and bodies, it is appropriate to follow a stepwise approach, starting with a small number of jointly assessed medicinal products and only at a later stage requiring joint clinical assessments to be carried out for other medicinal products undergoing the centralised marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council and where those medicinal products are subsequently authorised for a new therapeutic indication.
#2187591
táirgí íocshláinte atá údaraithe san Aontas ar foilsíodh tuarascáil maidir leis an measúnú cliniciúil comhpháirteach ina leith, i gcásanna ina ndeonófar údarú de bhun an dara fomhír d’Airteagal 6(1) de Threoir 2001/83/CE d’athrú ar údarú margaíochta atá ann cheana agus a fhreagraíonn do thásc teiripeach nua;
medicinal products authorised in the Union for which a joint clinical assessment report has been published, in cases where an authorisation is granted pursuant to the second subparagraph of Article 6(1) of Directive 2001/83/EC for a variation to an existing marketing authorisation which corresponds to a new therapeutic indication;
#2187595
an 12 Eanáir 2025, i gcás táirgí íocshláinte ina bhfuil substaintí gníomhacha nua iontu agus a ndearbhaíonn an t-iarratasóir ina leith ina iarratas ar údarú arna thíolacadh chuig an nGníomhaireacht Leigheasra Eorpach go bhfuil substaint ghníomhach nua ann arb í cóireáil na hailse is tásc teiripeach di agus i gcás táirgí íocshláinte a rialaítear mar tháirgí íocshláinte ardteiripe de bhun Rialachán (CE) Uimh. 1394/2007 ó Pharlaimint na hEorpa agus ón gComhairle;
12 January 2025, for medicinal products with new active substances for which the applicant declares in its application for authorisation submitted to the European Medicines Agency that it contains a new active substance for which the therapeutic indication is the treatment of cancer and medicinal products which are regulated as advanced therapy medicinal products pursuant to Regulation (EC) No 1394/2007 of the European Parliament and of the Council;
#3221227
Beidh feidhm ag táille EUR 163200 maidir le hiarratas ar mhórathrú de chineál II mar a shainmhínítear in Airteagal 2, pointe 3, de Rialachán (CE) Uimh. 1234/2008 chun tásc teiripeach nua a chur leis nó tásc formheasta a mhodhnú.
A fee of EUR 163200 shall apply to an application for a major variation of type II as defined in Article 2, point 3, of Regulation (EC) No 1234/2008 for an addition of a new therapeutic indication or modification of an approved indication.