7693 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): Yervoy
Ipilimumab, Melanoma; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Mesothelioma, Malignant; Colorectal Neoplasms
Date of authorisation: 13/07/2011, Revision: 50, Authorised, Last updated: 07/12/2022ancer 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): 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: 49, Authorised, Last updated: 06/12/2022ctodermal 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): 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): 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: 51, Authorised, Last updated: 07/12/2022ctodermal 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): 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): Ceprotin (updated)
human protein C, Purpura Fulminans; Protein C Deficiency
Date of authorisation: 16/07/2001, Revision: 18, Authorised, Last updated: 02/02/2023PDF/140.65 KB) (PDF/140.65 KB) German (PDF/143.05 KB) (PDF/143.05 … -
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Human medicine European public assessment report (EPAR): NexoBrid (updated)
proteolytic enzymes enriched in bromelain, Debridement
Date of authorisation: 18/12/2012,, 
, Revision: 14, Authorised, Last updated: 25/01/2023
PDF/119.43 KB) (PDF/119.43 KB) German (PDF/121.05 KB) (PDF/121.05 … -
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Human medicine European public assessment report (EPAR): Qdenga (updated)
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
PDF/122.26 KB) (PDF/122.26 KB) German (PDF/125.7 KB) (PDF/125.7 … -
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Human medicine European public assessment report (EPAR): Metalyse (updated)
tenecteplase, Myocardial Infarction
Date of authorisation: 23/02/2001, Revision: 22, Authorised, Last updated: 23/01/2023PDF/82.46 KB) (PDF/82.46 KB) German (PDF/104.14 KB) (PDF/104.14 … -
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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): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 18/01/2007, Revision: 33, Authorised, Last updated: 28/09/2022PDF/111.44 KB) (PDF/111.44 KB) German (PDF/109.33 KB) (PDF/109.33 … -
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Human medicine European public assessment report (EPAR): Jylamvo (updated)
Methotrexate, Arthritis, Psoriatic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Psoriasis; Arthritis, Rheumatoid; Arthritis
Date of authorisation: 29/03/2017, Revision: 11, Authorised, Last updated: 30/01/2023PDF/94.73 KB) (PDF/94.73 KB) German (PDF/83.57 KB) (PDF/83.57 … -
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Human medicine European public assessment report (EPAR): Alecensa (updated)
alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017,, Revision: 13, Authorised, Last updated: 23/01/2023
PDF/76.82 KB) (PDF/76.82 KB) German (PDF/77.1 KB) (PDF/77.1 KB … -
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Human medicine European public assessment report (EPAR): Topotecan Eagle
topotecan (as hydrochloride), Carcinoma; Small Cell Lung Carcinoma
Date of authorisation: 22/12/2011,, Revision: 2, Withdrawn, Last updated: 14/11/2014
PDF/960.04 KB) (PDF/960.04 KB) German (PDF/959.98 KB) (PDF/959.98 … -
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Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 15, Authorised, Last updated: 17/01/2023
PDF/87.09 KB) (PDF/87.09 KB) German (PDF/87.51 KB) (PDF/87.51 … -
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Human medicine European public assessment report (EPAR): Cotellic (updated)
cobimetinib hemifumarate, Melanoma
Date of authorisation: 20/11/2015, Revision: 13, Authorised, Last updated: 17/01/2023PDF/76.59 KB) (PDF/76.59 KB) German (PDF/77.22 KB) (PDF/77.22 … -
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Human medicine European public assessment report (EPAR): Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
human IgG1 monoclonal antibody specific for human interleukin-1 alpha, Colorectal Neoplasms
Date of refusal: 08/12/2017, Refused, Last updated: 13/11/2017authorisation is XBiotech Germany GmbH. The company requested … -
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Human medicine European public assessment report (EPAR): Helixate NexGen
octocog alfa, Hemophilia A
Date of authorisation: 04/08/2000, Revision: 31, Withdrawn, Last updated: 02/06/2020PDF/652.41 KB) (PDF/652.41 KB) German (PDF/652.26 KB) (PDF/652.26 … -
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Human medicine European public assessment report (EPAR): Picato
Ingenol mebutate, Keratosis, Actinic
Date of authorisation: 15/11/2012,, Revision: 10, Withdrawn, Last updated: 31/07/2020
PDF/633.85 KB) (PDF/633.85 KB) German (PDF/633.57 KB) (PDF/633.57 … -
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Human medicine European public assessment report (EPAR): Iblias
octocog alfa, Hemophilia A
Date of authorisation: 18/02/2016,, Revision: 4, Withdrawn, Last updated: 18/02/2020
PDF/635.97 KB) (PDF/635.97 KB) German (PDF/635.46 KB) (PDF/635.46 … -
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Veterinary medicine European public assessment report (EPAR): Nobivac Piro
babesia canis, inactivated, babesia rossi, inactivated, Dogs
Date of authorisation: 02/09/2004, Revision: 4, Withdrawn, Last updated: 30/05/2013PDF/513.51 KB) (PDF/513.51 KB) German (PDF/520.41 KB) (PDF/520.41 …