130 results
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Human medicine European public assessment report (EPAR): Sogroya
Somapacitan, Growth
Date of authorisation: 31/03/2021,
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, Revision: 1, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Qdenga
Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated, Dengue virus, serotype 2, live, attenuated, Dengue
Date of authorisation: 05/12/2022,, Authorised, Last updated: 30/01/2023
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National expert: Sonja Matt, Paul Ehrlich Institute (updated)
- Declaration of interests - 80.51 KB | PDF
- Curriculum Vitae - 17.26 KB | PDF
DNA repair, cell death and senescence Joint project to identify … -
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National expert: Martina Weise, Federal Institute For Drugs And Medical Devices (updated)
- Declaration of interests - 80.21 KB | PDF
- Curriculum Vitae - 24.46 KB | PDF
estrogen on growth plate senescence ad epiphyseal fusion. Proc … is associated with delayed senescence of the growth plate in rabbits … -
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,
, , Revision: 41, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Libmeldy
atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,, , Revision: 5, Authorised, Last updated: 12/09/2022
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Human medicine European public assessment report (EPAR): Cerdelga
eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015,, , Revision: 13, Authorised, Last updated: 11/01/2022
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,, , Revision: 35, Authorised, Last updated: 21/02/2023
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Human medicine European public assessment report (EPAR): Dacogen
Decitabine, Leukemia, Myeloid
Date of authorisation: 20/09/2012,, Revision: 16, Authorised, Last updated: 20/07/2021
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Human medicine European public assessment report (EPAR): ChondroCelect
characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins, Cartilage Diseases
Date of authorisation: 05/10/2009, Revision: 6, Withdrawn, Last updated: 12/01/2017 -
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Human medicine European public assessment report (EPAR): Maci
autologous cultured chondrocytes, Fractures, Cartilage
Date of authorisation: 27/06/2013,
Date of refusal: 26/04/2013, Revision: 4, Withdrawn, Last updated: 05/07/2018 -
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Human medicine European public assessment report (EPAR): Angiox
Bivalirudin, Acute Coronary Syndrome
Date of authorisation: 20/09/2004, Revision: 22, Withdrawn, Last updated: 14/09/2018 -
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Human medicine European public assessment report (EPAR): Turalio
Pexidartinib, Giant Cell Tumor of Tendon Sheath; Synovitis, Pigmented Villonodular
Date of refusal: 28/10/2020,, , Refused, Last updated: 18/12/2020
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National expert: Alessia Calzolari, Italian Medicines Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 19.65 KB | PDF
R, Calzolari A, Biffoni M, Senese M, Riti V, Petrucci E, Pasquini … -
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National expert: Rosana Sibug, Medicines Evaluation Board (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 20.67 KB | PDF
the CA1 and CA3 areas of senescent Brown Norway rats. Brain … -
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National expert: Kristian Wennmalm, Medical Products Agency (updated)
- Declaration of interests - 81.12 KB | PDF
- Curriculum Vitae - 19.76 KB | PDF
expression signature of in vitro senescence resembles mouse but not … -
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Human medicine European public assessment report (EPAR): Pandemrix
split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A, Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 20/05/2008, Revision: 23, Withdrawn, Last updated: 10/06/2016 -
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National expert: Valentina Conti, Italian Medicines Agency (updated)
- Declaration of interests - 79.77 KB | PDF
- Curriculum Vitae - 22.65 KB | PDF
Telomere-dependent replicative senescence of B and T cells from patients … -
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National expert: Anastasia Mountaki, National Organization For Medicines (updated)
- Declaration of interests - 79.84 KB | PDF
- Curriculum Vitae - 36.87 KB | PDF
in Pharmaceutical Company Galenica (Pharmaceutical Company … -
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National expert: Dolores Serrano, European Medicines Agency (updated)
- Declaration of interests - 79.84 KB | PDF
- Curriculum Vitae - 34.46 KB | PDF
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National expert: Christian Marx, Paul Ehrlich Institute (updated)
- Declaration of interests - 79.86 KB | PDF
- Curriculum Vitae - 23.71 KB | PDF
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National expert: Olga Maria Palomino, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 43.93 KB | PDF
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Withdrawn application: Contusugene Ladenovec Gendux
date of withdrawal: 12/06/2009, Initial authorisation, Last updated: 23/07/2009 -
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Withdrawn application: Cervarix
human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed), date of withdrawal: 22/10/2021, Post-authorisation, Last updated: 10/01/2022 -
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National expert: Flora Musuamba Tshinanu, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 80.09 KB | PDF
- Curriculum Vitae - 29.05 KB | PDF