20493 results
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Human medicine European public assessment report (EPAR): Dupixent (updated)
dupilumab, Dermatitis, Atopic; Prurigo; Esophageal Diseases; Asthma; Sinusitis
Date of authorisation: 26/09/2017, Revision: 25, Authorised, Last updated: 23/03/2023 -
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Human medicine European public assessment report (EPAR): MabThera (updated)
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 02/06/1998, Revision: 58, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Ocrevus (updated)
ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018, Revision: 16, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Kadcyla (updated)
trastuzumab emtansine, Breast Neoplasms
Date of authorisation: 15/11/2013, Revision: 15, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Vegzelma (updated)
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 17/08/2022,
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, Revision: 2, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Polivy (updated)
polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020,, 
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, Revision: 5, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Elebrato Ellipta (updated)
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 15/11/2017, Revision: 11, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Suliqua (updated)
insulin glargine, lixisenatide, Diabetes Mellitus, Type 2
Date of authorisation: 11/01/2017, Revision: 10, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Trelegy Ellipta (updated)
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 15/11/2017, Revision: 10, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Pradaxa (updated)
Dabigatran etexilate mesilate, Arthroplasty, Replacement; Venous Thromboembolism
Date of authorisation: 17/03/2008, Revision: 39, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Zynlonta (updated)
loncastuximab tesirine, Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Date of authorisation: 20/12/2022,, , Revision: 1, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Simponi (updated)
Golimumab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Arthritis, Rheumatoid
Date of authorisation: 01/10/2009, Revision: 44, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Hexacima (updated)
hepatitis B surface antigen, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett), Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 28, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): NovoRapid (updated)
insulin aspart, Diabetes Mellitus
Date of authorisation: 07/09/1999, Revision: 32, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, , Revision: 16, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Xolair (updated)
omalizumab, Asthma; Urticaria
Date of authorisation: 25/10/2005, Revision: 45, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Hexyon (updated)
filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Diphtheria toxoid, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 29, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): PreHevbri (updated)
hepatitis B surface antigen, Hepatitis B
Date of authorisation: 25/04/2022,, Revision: 1, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Darzalex (updated)
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,
, , Revision: 20, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Keppra (updated)
levetiracetam, Epilepsy
Date of authorisation: 29/09/2000, Revision: 53, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Insulin lispro Sanofi (updated)
insulin lispro, Diabetes Mellitus
Date of authorisation: 19/07/2017,, Revision: 8, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Herzuma (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018,, Revision: 19, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Noxafil (updated)
posaconazole, Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis
Date of authorisation: 25/10/2005, Revision: 36, Authorised, Last updated: 22/03/2023 -
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Human medicine European public assessment report (EPAR): Ultomiris (updated)
ravulizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 02/07/2019,, Revision: 10, Authorised, Last updated: 22/03/2023
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Human medicine European public assessment report (EPAR): Imcivree (updated)
Setmelanotide, Obesity
Date of authorisation: 16/07/2021,, , Revision: 7, Authorised, Last updated: 22/03/2023