21035 results
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Human medicine European public assessment report (EPAR): Trixeo Aerosphere (updated)
formoterol fumarate dihydrate, Glycopyrronium bromide, Budesonide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 09/12/2020, Revision: 5, Authorised, Last updated: 29/11/2023 -
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Human medicine European public assessment report (EPAR): Slenyto (updated)
melatonin, Sleep Initiation and Maintenance Disorders; Autistic Disorder
Date of authorisation: 20/09/2018, Revision: 10, Authorised, Last updated: 29/11/2023 -
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Human medicine European public assessment report (EPAR): Truxima (updated)
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Wegener Granulomatosis; Leukemia, Lymphocytic, Chronic, B-Cell; Microscopic Polyangiitis
Date of authorisation: 17/02/2017,
, Revision: 20, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Ruxience (updated)
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 01/04/2020,
, , Revision: 11, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Advate (updated)
Octocog alfa, Hemophilia A
Date of authorisation: 02/03/2004, Revision: 32, Authorised, Last updated: 29/11/2023 -
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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: 60, Authorised, Last updated: 29/11/2023 -
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Human medicine European public assessment report (EPAR): Vyvgart (updated)
Efgartigimod alfa, Myasthenia Gravis
Date of authorisation: 10/08/2022,, 
, Revision: 5, Authorised, Last updated: 28/11/2023
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Human medicine European public assessment report (EPAR): Riltrava Aerosphere (updated)
Budesonide, formoterol fumarate dihydrate, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 06/01/2022, Revision: 3, Authorised, Last updated: 28/11/2023 -
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Human medicine European public assessment report (EPAR): Pirfenidone Viatris (updated)
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 10/01/2023,
, Revision: 1, Authorised, Last updated: 28/11/2023
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Human medicine European public assessment report (EPAR): Zessly (updated)
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,, Revision: 12, Authorised, Last updated: 28/11/2023
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Human medicine European public assessment report (EPAR): Cyramza (updated)
Ramucirumab, Stomach Neoplasms
Date of authorisation: 19/12/2014, Revision: 16, Authorised, Last updated: 28/11/2023 -
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Human medicine European public assessment report (EPAR): Pravafenix (updated)
fenofibrate, Pravastatin, Dyslipidemias
Date of authorisation: 14/04/2011, Revision: 8, Authorised, Last updated: 28/11/2023 -
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Human medicine European public assessment report (EPAR): Tecartus (updated)
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,, , 
, Revision: 5, Authorised, Last updated: 28/11/2023
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Human medicine European public assessment report (EPAR): Orserdu (updated)
elacestrant, Breast Neoplasms
Date of authorisation: 15/09/2023,, Authorised, Last updated: 27/11/2023
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Human medicine European public assessment report (EPAR): Triumeq (updated)
dolutegravir sodium, lamivudine, abacavir (as sulfate), HIV Infections
Date of authorisation: 31/08/2014, Revision: 32, Authorised, Last updated: 27/11/2023 -
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Human medicine European public assessment report (EPAR): Pluvicto (updated)
lutetium (177Lu) vipivotide tetraxetan, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 09/12/2022,, Revision: 4, Authorised, Last updated: 27/11/2023
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Human medicine European public assessment report (EPAR): Prevenar 13 (updated)
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal Infections; Immunization
Date of authorisation: 09/12/2009, Revision: 45, Authorised, Last updated: 27/11/2023 -
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Human medicine European public assessment report (EPAR): Kivexa (updated)
abacavir, lamivudine, HIV Infections
Date of authorisation: 16/12/2004, Revision: 37, Authorised, Last updated: 27/11/2023 -
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Human medicine European public assessment report (EPAR): Apexxnar (updated)
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 8, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 10A, Pneumococcal polysaccharide serotype 11A, Pneumococcal polysaccharide serotype 12F, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 15b, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 22F, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 33F, Pneumococcal Infections
Date of authorisation: 14/02/2022,, Revision: 6, Authorised, Last updated: 27/11/2023
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Human medicine European public assessment report (EPAR): Tasigna (updated)
nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 19/11/2007, Revision: 45, Authorised, Last updated: 27/11/2023 -
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Human medicine European public assessment report (EPAR): Somavert (updated)
Pegvisomant, Acromegaly
Date of authorisation: 12/11/2002, Revision: 28, Authorised, Last updated: 27/11/2023 -
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Human medicine European public assessment report (EPAR): Holoclar (updated)
ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation; Corneal Diseases
Date of authorisation: 17/02/2015,, , , Revision: 10, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Betaferon (updated)
interferon beta-1b, Multiple Sclerosis
Date of authorisation: 30/11/1995, Revision: 36, Authorised, Last updated: 24/11/2023 -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva (updated)
emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016,, Revision: 8, Authorised, Last updated: 24/11/2023
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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: 40, Authorised, Last updated: 24/11/2023