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Summary of opinion: Yescarta
axicabtagene ciloleucel, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022Yescarta: Pending EC decision … opinion1 (post authorisation) Yescarta axicabtagene ciloleucel … for the medicinal product Yescarta. The marketing authorisation … -
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Opinion/decision on a Paediatric investigation plan (PIP): Yescarta, axicabtagene ciloleucel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002010-PIP01-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 15/04/2020, Last updated: 09/03/2021, Compliance check: XInvented name Yescarta Active substance axicabtagene … axicabtagene ciloleucel (YESCARTA), (EMEA-002010-PIP01-16-M02 … axicabtagene ciloleucel (YESCARTA), (EMEA-002010-PIP01-16-M02 … -
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Human medicine European public assessment report (EPAR): Yescarta
axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,
, 
, Revision: 7, Authorised, Last updated: 08/07/2021
Yescarta Lymphoma, Non-Hodgkin Lymphoma Lymphoproliferative … Yescarta … EMA/495475/2018 EMEA/H/C/004480 Yescarta (axicabtagene ciloleucel … -
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Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel) for: Treatment of primary mediastinal large B-cell lymphoma
Date of designation: 09/10/2015, Positive, Last updated: 15/09/2021been authorised in the EU as Yescarta since 23 August 2018. The … Yescarta Yescarta axicabtagene ciloleucel Autologous … the orphan designation of Yescarta at the time of marketing … -
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Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor (axicabtagene ciloleucel) for: Treatment of diffuse large B-cell lymphoma
Date of designation: 16/12/2014, Positive, Last updated: 15/09/2021been authorised in the EU as Yescarta since 23 August 2018. The … Yescarta Yescarta axicabtagene ciloleucel Autologous … the orphan designation of Yescarta at the time of marketing … -
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National expert: Susy Yeshika Olave-Quispe, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.84 KB | PDF
- Curriculum Vitae - 22.96 KB | PDF
Susy Yeshika Olave-Quispe … Susy Yeshika Olave-Quispe … Vitae PERSONAL INFORMATION Susy Yeshika Olave-Quispe WORK EXPERIENCE June … -
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Classifications as minor-use-minor-species and limited-market according to former EMA policy
Last updated: 06/12/2021ologicals Ducks MUMS/yes 05/11/2021 Immunologicals … Sheep, goats, cattle MUMS/yes 07/10/2021 Ophthalmologicals … Immunologicals Sheep, goats MUMS/yes 15/07/2021 Immunologicals …
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Press release: First two CAR-T cell medicines recommended for approval in the European Union
CHMP, Last updated: 29/06/2018Development of Kymriah and Yescarta supported through PRIME The … Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel … their cancer. Kymriah and Yescarta are also the first medicines … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 June 2018
CHMP, Last updated: 29/06/2018Yescarta … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2022
CHMP, Last updated: 22/04/2022Yescarta … -
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News: Committee for Advanced Therapies re-elects Christian Schneider as chair
CAT, Last updated: 09/03/2012his re-election by majority yesterday, during its March plenary … -
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National expert: Birgit Tans, European Medicines Agency (updated)
- Declaration of interests - 79.85 KB | PDF
- Curriculum Vitae - 16.34 KB | PDF
in a University Hospital. Yes, some of my collegues have … -
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Orphan designation: L-cystine bis(N-methylpiperazide) for: Treatment of cystinuria
Date of designation: 27/06/2018, Positive, Last updated: 30/04/20212019 and subsequently to YES Pharmaceutical Development … marketing authorisation. YES Pharmaceutical Development … -
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Orphan designation: 1,2:5,6-Dianhydrogalactitol for: Treatment of glioma
Date of designation: 24/01/2013, Positive, Last updated: 28/04/20212019 and subsequently to YES Pharmaceutical Development … marketing authorisation. YES Pharmaceutical Development … -
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Orphan designation: (R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea (ceclazepide) for: Treatment of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 14/12/2015, Positive, Last updated: 02/03/2021sponsorship was transferred to YES Pharmaceutical Development … now known as ceclazepide. YES Pharmaceutical Development … -
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Orphan designation: R-1-[2,3-dihydro-2-oxo-1-pivaloylmethyl-5-(2-pyridyl)-1 H-1,4-benzodiazepin-3-yl]-3-(3-methylaminophenyl)urea (netazepide) for: Treatment of gastric carcinoid
Date of designation: 14/06/2007, Positive, Last updated: 02/03/2021sponsorship was transferred to YES Pharmaceutical Development … -
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Orphan designation: Tadekinig alfa for: Treatment of haemophagocytic lymphohistiocytosis
Date of designation: 14/10/2016, Positive, Last updated: 19/02/2021sponsorship was transferred to YES Pharmaceutical Development … 14/10/2016 PositiveEU/3/16/1763 YES Pharmaceutical Development … -
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Opinion/decision on a Paediatric investigation plan (PIP): (S)-lactic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001953-PIP01-16, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal gel
Decision date: 09/09/2016, Last updated: 27/10/2016, Compliance check: Xof pregnancy Vaginal use YES Pharmaceutical Development … application submitted by YES Pharmaceutical Development … decision is addressed to YES Pharmaceutical Development … -
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Orphan designation: HLA-A2 restricted CD8 T-cell line expressing MART-1 T-cell receptor for: Treatment of MART-1 YES malignant melanoma in HLA-A2 YES patients
Date of designation: 21/06/2004, Positive, Last updated: 15/06/2009receptorTreatment of MART-1 YES malignant melanoma in HLA-A2 YES patients 21/06/2004 PositiveE … -
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Opinion/decision on a Paediatric investigation plan (PIP): heparin sodium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases; Haematology-Hemostaseology
PIP number: EMEA-002885-PIP01-20, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection/infusion
Decision date: 29/01/2021, Last updated: 06/10/2021, Compliance check: XIntravenous use Subcutaneous use YES Pharmaceutical Development … application submitted by YES Pharmaceutical Development … decision is addressed to YES Pharmaceutical Development … -
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News: Public consultation on the publication and access to clinical-trial data now closed
Last updated: 01/10/2013clinical-trial data ended yesterday, 30 September 2013. The draft … -
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Orphan designation: Human frataxin fused to TAT cell-penetrating peptide for: Treatment of Friedreich’s ataxia
Date of designation: 21/08/2020, Positive, Last updated: 25/11/2020the European Commission to YES Pharmaceutical Development … -
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Orphan designation: Lisocabtagene maraleucel for: Treatment of primary mediastinal large B-cell lymphoma
Date of designation: 19/11/2018, Withdrawn, Last updated: 04/05/2022designation, the medicine Yescarta (axicabtagene ciloleucel … the authorised treatment Yescarta. These assumptions will need … designation, the medicine Yescarta (axicabtagene ciloleucel … -
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Orphan designation: Autologous CD34+ cells transfected with a lentiviral vector containing codon optimised RPS19 gene for: Treatment of Diamond-Blackfan anaemia (updated)
Date of designation: 20/08/2021, Positive, Last updated: 08/06/2022anaemiaPositiveEU/3/21/2488 20/08/2021 Yes Pharmaceutical Development … sponsorship was transferred to Yes Pharmaceutical Development … -
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Orphan designation: Autologous CD34+ hematopoietic stem and progenitor cells transfected with zinc finger nuclease mRNAs SB-mRENH1 and SB-mRENH2 for: Treatment of sickle cell disease
Date of designation: 19/02/2021, Positive, Last updated: 25/04/2022diseasePositiveEU/3/21/2406 19/02/2021 Yes Pharmaceutical Development … sponsorship was transferred to Yes Pharmaceutical Development …