115 results
Keyword Trabectedin Remove keyword
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Referral: Yondelis
trabectedin, associated names: Yondelis, Article 20 procedures
Status: European Commission final decision, opinion/position date: 24/07/2020, EC decision date: 24/09/2020, Last updated: 09/10/2020Yondelis Yondelis trabectedin trabectedin trabectedin … -
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Human medicine European public assessment report (EPAR): Yondelis
trabectedin, Ovarian Neoplasms; Sarcoma
Date of authorisation: 17/09/2007, Revision: 27, Authorised, Last updated: 25/03/2022trabectedin … Yondelis, INN-trabectedin EMA/262441/2015 EMEA/H/C/000773 … for the public Yondelis trabectedin This is a summary of the … -
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Human medicine European public assessment report (EPAR): Yondelis
trabectedin, Sarcoma
Date of refusal: 07/09/2004, Refused, Last updated: 20/11/2003trabectedin … Nonproprietary Name (INN): trabectedin On 24 July 2003 the … substance of Yondelis is trabectedin, a new anti-cancer medicinal … -
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Orphan designation: trabectedin for: Treatment of ovarian cancer
Date of designation: 17/10/2003, Expired, Last updated: 27/11/2019trabectedin Overview … trabectedin … -
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Orphan designation: Ecteinascidin 743 (trabectedin) for: Treatment of soft tissue sarcoma
Date of designation: 30/05/2001, Expired, Last updated: 03/10/2017Ecteinascidin 743 (trabectedin) Overview Please note that … medicine is now known as trabectedin. What is soft tissue sarcoma … Ecteinascidin 743 (trabectedin … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2020
CHMP, Last updated: 28/02/2020trabectedin), used to treat ovarian cancer … -
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National expert: Ricardo Cubedo, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 81.22 KB | PDF
- Curriculum Vitae - 21.01 KB | PDF
Tabernero J. Phase II study of trabectedin in pretreated patients with advanced … 04/2013-(current) PharmaMar Trabectedin Soft Tissue Sarcoma 11/2013-11/2013 … -
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National expert: Esther Brandon, Medicines Evaluation Board (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 22.16 KB | PDF
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National expert: Juan Fernando Martínez Leal, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 80.37 KB | PDF
- Curriculum Vitae - 26.27 KB | PDF
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News: Authorised uses of cancer medicine Yondelis unchanged following review of new data
CHMP, Last updated: 24/07/2020 -
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Human medicine European public assessment report (EPAR): Rubraca
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,,
, Revision: 11, Authorised, Last updated: 08/12/2022
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Human medicine European public assessment report (EPAR): Lynparza (updated)
Olaparib, Ovarian Neoplasms
Date of authorisation: 16/12/2014, Revision: 20, Authorised, Last updated: 24/03/2023 -
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Human medicine European public assessment report (EPAR): Halaven
Eribulin, Breast Neoplasms; Liposarcoma
Date of authorisation: 17/03/2011, Revision: 29, Authorised, Last updated: 14/11/2022 -
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Human medicine European public assessment report (EPAR): Votrient
pazopanib, Carcinoma, Renal Cell
Date of authorisation: 14/06/2010, Revision: 29, Authorised, Last updated: 08/11/2021 -
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National expert: Saskia Litiere, European Medicines Agency (updated)
- Declaration of interests - 80.18 KB | PDF
- Curriculum Vitae - 27.76 KB | PDF
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
CHMP, Last updated: 24/07/2020that the use of Yondelis (trabectedin) in treating ovarian cancer … -
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Withdrawn application: Vynfinit
date of withdrawal: 16/05/2014, Initial authorisation, Last updated: 14/08/2014 -
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Withdrawn application: Jenzyl
date of withdrawal: 27/11/2012, Initial authorisation, Last updated: 18/02/2013 -
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Withdrawn application: Zemfirza
date of withdrawal: 19/09/2016, Initial authorisation, Last updated: 21/12/2016 -
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National expert: Ron Mathot, Medicines Evaluation Board (updated)
- Declaration of interests - 80.96 KB | PDF
- Curriculum Vitae - 54.52 KB | PDF
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Referral: Sandimmun and associated names
ciclosporin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 27/06/2013, EC decision date: 31/10/2013, Last updated: 20/12/2013 -
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Referral: Sandimmun Neoral and associated names
ciclosporin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 27/06/2013, EC decision date: 31/10/2013, Last updated: 20/12/2013 -
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PRAC recommendations on safety signals (updated)
Last updated: 06/03/2023 -
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COMP: Agendas, minutes and meeting reports (updated)
Last updated: 17/03/2023 -
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Paediatric Committee (PDCO): 17-20 May 2022
Virtual meeting, from 17/05/2022 to 20/05/2022, Last updated: 21/07/2022