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Human medicine European public assessment report (EPAR): Yescarta (updated)
Date of authorisation: 23/08/2018,
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, Revision: 4, Authorised, Last updated: 03/02/2020
EMA/495475/2018 EMEA/H/C/004480 Yescarta (axicabtagene ciloleucel … ciloleucel) An overview of Yescarta and why it is authorised … authorised in the EU What is Yescarta and what is it used for … -
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Orphan designation: for: Treatment of primary mediastinal large B-cell lymphoma
Date of first decision: 09/10/2015, Positive, Last updated: 10/09/2018been authorised in the EU as Yescarta since 23 August 2018. Expand … the orphan designation of Yescarta at the time of marketing … Yescarta Yescarta axicabtagene ciloleucel Autologous … -
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Orphan designation: for: Treatment of diffuse large B-cell lymphoma
Date of first decision: 16/12/2014, Positive, Last updated: 10/09/2018been authorised in the EU as Yescarta since 23 August 2018. Expand … the orphan designation of Yescarta at the time of marketing … Yescarta Yescarta axicabtagene ciloleucel Autologous … -
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National expert: Susy Yeshika Olave-Quispe, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 78.96 KB | PDF
- Curriculum Vitae - 94.64 KB | PDF
Susy Yeshika Olave-Quispe … Susy Yeshika Olave-Quispe … -
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Classifications as minor-use-minor-species and limited-market (updated)
Last updated: 03/02/2020Immunologicals Pigs MUMS/yes 12/09/2019 Sensory organs … Immunologicals Horses MUMS/yes 12/09/2019 Antineoplastic … Immunologicals Cattle MUMS/yes 16/04/2019 Cardiovascular …
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Press release: First two CAR-T cell medicines recommended for approval in the European Union
CHMP, Last updated: 29/06/2018release - CHMP - Kymriah and Yescarta - June 2018 30 Churchill … Development of Kymriah and Yescarta supported through PRIME … Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel … -
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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: 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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Orphan designation: for: Treatment of primary mediastinal large B-cell lymphoma
Date of first decision: 19/11/2018, Positive, Last updated: 25/02/2019designation, the medicine Yescarta (axicabtagene ciloleucel … the authorised treatment Yescarta. These assumptions will need … -
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Orphan designation: for: Treatment in haematopoietic stem cell transplantation
Date of first decision: 14/10/2016, Positive, Last updated: 24/04/2019sponsorship was transferred to YES Pharmaceuticals 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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Opinion/decision on a Paediatric investigation plan (PIP):
Decision type: W: decision granting a waiver in all age groups for all conditions/indications, PIP number: EMEA-001953-PIP01-16, decision date: 09/09/2016, Last updated: 27/10/2016, compliance check: Xapplication submitted by YES Pharmaceutical Development … decision is addressed to YES Pharmaceutical Development … name of the PIP applicant: YES Pharmaceutical Development … -
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Orphan designation: for: Treatment of MART-1 YES malignant melanoma in HLA-A2 YES patients
Date of first decision: 21/06/2004, Positive, Last updated: 15/06/2009condition Treatment of MART-1 YES malignant melanoma in HLA-A2 YES patients Date of first decision … -
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Orphan designation: for: Treatment of spinal muscular atrophy
Date of first decision: 14/12/2018, Positive, Last updated: 07/03/2019the European Commission to Yes Pharmaceutical Development … -
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Orphan designation: for: Treatment of phenylalanine hydroxylase deficiency
Date of first decision: 14/12/2018, Positive, Last updated: 08/03/2019the European Commission to Yes Pharmaceutical Development … -
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Herbal medicinal products: questions and answers
traditional-use registration)? Yes. Section 3.4 (“ Procedure … simplified registration procedure? Yes. According to Article 16c(1)(c … of Directive 2001/83/EC? Yes. As mentioned in Section 5.4 …