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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,
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, Revision: 6, Authorised, Last updated: 26/06/2020
Yescarta Lymphoma, Follicular Lymphoma … 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 first decision: 09/10/2015, Positive, Last updated: 10/09/2018been authorised in the EU as Yescarta since 23 August 2018. Expand … 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 first decision: 16/12/2014, Positive, Last updated: 10/09/2018been authorised in the EU as Yescarta since 23 August 2018. Expand … 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 - 79.8 KB | PDF
- Curriculum Vitae - 22.88 KB | PDF
Vitae PERSONAL INFORMATION Susy Yeshika Olave-Quispe WORK EXPERIENCE September … declaration of interests I, Susy Yeshika Olave-Quispe Organisation/Company … website. Full Name: Susy Yeshika Olave-Quispe Date: 2020-12-28 For … -
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Classifications as minor-use-minor-species and limited-market
Last updated: 08/07/2020Immunologicals Cattle MUMS/yes 23/04/2020 Immunologicals … Immunologicals Cattle MUMS/yes 18/03/2020 Various Pigs MUMS yes 18/03/2020 Antiparasitic … and repellents Salmon MUMS/yes 18/03/2020 Antiparasitic …
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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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National expert: Greet Musch, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 78.92 KB | PDF
- Curriculum Vitae - 71.96 KB | PDF
to declare, please click 'Yes' to the relevant questions … 2020) 2.1 Employment No @ Yes O Employment with a pharmaceutical … company. 2.2 Consultancy No 0 Yes Q Consultancy to a pharmaceutical … -
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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: Lisocabtagene maraleucel for: Treatment of primary mediastinal large B-cell lymphoma (updated)
Date of first decision: 19/11/2018, Positive, Last updated: 09/02/2021designation, the medicine Yescarta (axicabtagene ciloleucel … the authorised treatment Yescarta. These assumptions will need … -
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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): (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: XContact for public enquiries YES Pharmaceutical Development … application submitted by YES Pharmaceutical Development … decision is addressed to YES Pharmaceutical Development … -
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National expert: Birgit Tans, European Medicines Agency (updated)
- Declaration of interests - 79.83 KB | PDF
- Curriculum Vitae - 16.19 KB | PDF
in a University Hospital. Yes, some of my collegues have … -
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Orphan designation: Radio-iodinated (131I) anti-CD45 murine monoclonal antibody 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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Orphan designation: Tadekinig alfa for: Treatment of haemophagocytic lymphohistiocytosis (updated)
Date of first decision: 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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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 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: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase 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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Orphan designation: axicabtagene ciloleucel for: Treatment of marginal zone lymphoma
Date of first decision: 26/06/2020, Positive, Last updated: 24/09/2020lymphoma, under the name Yescarta. The medicine was not authorised … -
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Orphan designation: Human frataxin fused to TAT cell-penetrating peptide for: Treatment of Friedreich’s ataxia
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020the European Commission to YES Pharmaceutical Development … -
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Orphan designation: Infigratinib for: Treatment of cholangiocarcinoma
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020the European Commission to YES Pharmaceutical Development … -
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Orphan designation: Adeno-associated virus serotype HSC15 expressing human arylsulfatase A gene for: treatment of metachromatic leukodystrophy
Date of first decision: 26/06/2020, Positive, Last updated: 24/09/2020the European Commission to YES Pharmaceutical Development … -
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National expert: Robert Burman, Medical Products Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 21.23 KB | PDF
DOI 10.1002/pca.2704 3. Burman R, Yeshak MY, Larsson S, Craik DJ … Etnopharm 2013 145(3):746-57. 6. Yeshak MY, Burman R, Eriksson C … 2012 287(32):27001-6. 8. Yeshak MY, Göransson U, Burman … -
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Herbal medicinal products: questions and answers
Last updated: 18/12/2017traditional-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 …
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Questions and answers: Orphan-designation application
Last updated: 31/12/2009indication which is orphan? Yes, under certain circumstances … opinion issued by the COMP? Yes, a sponsor can appeal an opinion …
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Orphan designation: Artesunate for: Treatment of malaria
Date of first decision: 28/02/2020, Positive, Last updated: 09/09/2020the European Commission to YES Pharmaceutical Development …