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Medicine
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Human medicine European public assessment report (EPAR): Xolair (updated)
omalizumab, Asthma; Urticaria
Date of authorisation: 25/10/2005, Revision: 48, Authorised, Last updated: 29/11/2023 -
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Human medicine European public assessment report (EPAR): Omidria (updated)
ketorolac, phenylephrine, Lens Implantation, Intraocular; Pain, Postoperative
Date of authorisation: 28/07/2015, Revision: 9, Authorised, Last updated: 29/11/2023 -
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Human medicine European public assessment report (EPAR): Enhertu (updated)
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,,
, Revision: 13, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Pepaxti (updated)
Melphalan flufenamide hydrochloride, Multiple Myeloma
Date of authorisation: 17/08/2022, Revision: 3, Authorised, Last updated: 29/11/2023 -
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Human medicine European public assessment report (EPAR): Nuceiva (updated)
Botulinum toxin type A, Skin Aging
Date of authorisation: 27/09/2019,, Revision: 5, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Trumenba (updated)
Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B, Meningitis, Meningococcal
Date of authorisation: 24/05/2017, Revision: 16, Authorised, Last updated: 29/11/2023 -
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Human medicine European public assessment report (EPAR): Riximyo (updated)
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 15/06/2017,, Revision: 14, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Blitzima (updated)
rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,, Revision: 19, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Rixathon (updated)
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 15/06/2017,, Revision: 12, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Orgovyx (updated)
relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022,, Revision: 8, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Trizivir (updated)
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 43, Authorised, Last updated: 29/11/2023 -
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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,,
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, 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