7820 results
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The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Berlin, Germany
one-by-one EDV-GmbH, Berlin, Germany, from 24/09/2018 to 26/09/2018, Last updated: 14/06/2018training course, Berlin, Germany … training course, Berlin, Germany … one-by-one EDV-GmbH, Berlin, Germany Course # 18515 OVERVIEW EudraVigilance … -
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Committee for Advanced Therapies (CAT) and the German Society for Transfusion Medicine and Immunohaematology (DGTI) workshop on advanced-therapy medicinal products: How to bring cell-based medicinal products successfully to the market
Dresden, Germany, 11/09/2014, Last updated: 21/10/2014Advanced Therapies (CAT) and the German Society for Transfusion Medicine … Advanced Therapies (CAT) and the German Society for Transfusion Medicine … Congress Centrum, Dresden, GERMANY Introduction … -
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Human medicine European public assessment report (EPAR): Sunitinib Accord
sunitinib, Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors
Date of authorisation: 11/02/2021,
, 
, Revision: 1, Authorised, Last updated: 14/12/2021
Nerve Tissue Neoplasms, Germ Cell and Embryonal Gastrointestinal … PDF/159.06 KB) (PDF/159.06 KB) German (PDF/161.35 KB) (PDF/161.35 … -
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Human medicine European public assessment report (EPAR): Keytruda
Pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
Date of authorisation: 17/07/2015, Revision: 50, Authorised, Last updated: 28/04/2023ctodermal Tumors Neoplasms, Germ Cell and Embryonal Nevi … PDF/162.56 KB) (PDF/162.56 KB) German (PDF/163.68 KB) (PDF/163.68 … -
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Human medicine European public assessment report (EPAR): Yervoy
Ipilimumab, Melanoma; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Mesothelioma, Malignant; Colorectal Neoplasms
Date of authorisation: 13/07/2011, Revision: 51, Authorised, Last updated: 03/04/2023ancer Neoplasms Neoplasms, Germ Cell and Embryonal Neuroectodermal … PDF/142.83 KB) (PDF/142.83 KB) German (PDF/145.59 KB) (PDF/145.59 … -
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Human medicine European public assessment report (EPAR): Opdivo
nivolumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Mesothelioma; Colorectal Neoplasms
Date of authorisation: 19/06/2015, Revision: 52, Authorised, Last updated: 28/03/2023ctodermal Tumors Neoplasms, Germ Cell and Embryonal Nevi … PDF/162.18 KB) (PDF/162.18 KB) German (PDF/168.54 KB) (PDF/168.54 … -
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Human medicine European public assessment report (EPAR): IntronA
interferon alfa-2b, Carcinoid Tumor; Leukemia, Hairy Cell; Lymphoma, Follicular; Hepatitis B, Chronic; Hepatitis C, Chronic; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Melanoma; Multiple Myeloma
Date of authorisation: 09/03/2000, Revision: 34, Withdrawn, Last updated: 15/12/2022Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Adenocarcinoma Carcinoma Neoplasms … -
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Human medicine European public assessment report (EPAR): Phelinun
melphalan hydrochloride, Multiple Myeloma; Hodgkin Disease; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Neuroblastoma; Ovarian Neoplasms; Hematopoietic Stem Cell Transplantation
Date of authorisation: 16/11/2020, Revision: 1, Authorised, Last updated: 24/11/2021Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms … PDF/133.9 KB) (PDF/133.9 KB) German (PDF/136.89 KB) (PDF/136.89 … -
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Human medicine European public assessment report (EPAR): Zynquista
Sotagliflozin, Diabetes Mellitus, Type 1
Date of authorisation: 26/04/2019,, Revision: 3, Withdrawn, Last updated: 16/08/2022
PDF/664.42 KB) (PDF/664.42 KB) German (PDF/665.21 KB) (PDF/665.21 … authorisation holder, Guidehouse Germany GmbH, which notified the … -
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Human medicine European public assessment report (EPAR): Kogenate Bayer
octocog alfa, Hemophilia A
Date of authorisation: 04/08/2000, Revision: 30, Withdrawn, Last updated: 02/03/2023PDF/639.44 KB) (PDF/639.44 KB) German (PDF/639.63 KB) (PDF/639.63 … -
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Human medicine European public assessment report (EPAR): Ronapreve
casirivimab, imdevimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 4, Authorised, Last updated: 28/04/2023
PDF/122.97 KB) (PDF/122.97 KB) German (PDF/125.02 KB) (PDF/125.02 … -
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Human medicine European public assessment report (EPAR): Capecitabine Medac
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,, Revision: 13, Authorised, Last updated: 31/03/2023
PDF/189.4 KB) (PDF/189.4 KB) German (PDF/192.51 KB) (PDF/192.51 … -
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Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva
lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011,, Revision: 16, Withdrawn, Last updated: 21/03/2023
PDF/664.8 KB) (PDF/664.8 KB) German (PDF/665.21 KB) (PDF/665.21 … -
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Human medicine European public assessment report (EPAR): Nevirapine Teva
nevirapine, HIV Infections
Date of authorisation: 30/11/2009,, Revision: 11, Withdrawn, Last updated: 21/03/2023
PDF/652.99 KB) (PDF/652.99 KB) German (PDF/656.96 KB) (PDF/656.96 … -
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Human medicine European public assessment report (EPAR): Nimvastid
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/05/2009,, Revision: 10, Authorised, Last updated: 22/02/2023
PDF/104.46 KB) (PDF/104.46 KB) German (PDF/104.68 KB) (PDF/104.68 … -
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Human medicine European public assessment report (EPAR): Rasilez
aliskiren, Hypertension
Date of authorisation: 22/08/2007, Revision: 27, Authorised, Last updated: 23/02/2023PDF/80.05 KB) (PDF/80.05 KB) German (PDF/80.49 KB) (PDF/80.49 … -
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Human medicine European public assessment report (EPAR): Thiotepa Riemser
thiotepa, Hematopoietic Stem Cell Transplantation; Neoplasms
Date of authorisation: 26/03/2021,, Revision: 3, Authorised, Last updated: 16/02/2023
PDF/168.14 KB) (PDF/168.14 KB) German (PDF/170.83 KB) (PDF/170.83 … -
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Human medicine European public assessment report (EPAR): Spherox
spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases
Date of authorisation: 10/07/2017, Revision: 8, Authorised, Last updated: 20/02/2023PDF/116.92 KB) (PDF/116.92 KB) German (PDF/119.18 KB) (PDF/119.18 … Warthestr. 21 14513 Teltow GERMANY Active substance … -
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Human medicine European public assessment report (EPAR): Kerendia
Finerenone, Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022,, Revision: 1, Authorised, Last updated: 20/02/2023
PDF/117.81 KB) (PDF/117.81 KB) German (PDF/117.88 KB) (PDF/117.88 … -
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Human medicine European public assessment report (EPAR): Sildenafil Actavis (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009,, Revision: 16, Authorised, Last updated: 01/06/2023
PDF/91.88 KB) (PDF/91.88 KB) German (PDF/91.47 KB) (PDF/91.47 … -
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Human medicine European public assessment report (EPAR): Azacitidine betapharm
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 24/03/2020,, Revision: 5, Authorised, Last updated: 13/02/2023
PDF/171.19 KB) (PDF/171.19 KB) German (PDF/172.89 KB) (PDF/172.89 … -
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Veterinary medicine European public assessment report (EPAR): Coliprotec F4
live non-pathogenic Escherichia coli O8:K87, Pigs
Date of authorisation: 16/03/2015, Revision: 2, Withdrawn, Last updated: 23/11/2021PDF/283.25 KB) (PDF/283.25 KB) German (PDF/283.88 KB) (PDF/283.88 … -
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 3, Authorised, Last updated: 16/01/2023
PDF/147.18 KB) (PDF/147.18 KB) German (PDF/150.26 KB) (PDF/150.26 … -
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Human medicine European public assessment report (EPAR): Olanzapine Glenmark Europe
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 03/12/2009,, Revision: 14, Authorised, Last updated: 20/12/2022
PDF/76.05 KB) (PDF/76.05 KB) German (PDF/75.33 KB) (PDF/75.33 … -
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Human medicine European public assessment report (EPAR): Olanzapine Glenmark
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 03/12/2009,, Revision: 15, Authorised, Last updated: 20/12/2022
PDF/97.03 KB) (PDF/97.03 KB) German (PDF/75.18 KB) (PDF/75.18 …