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Human medicine European public assessment report (EPAR): Fasenra (updated)

benralizumab, Asthma
Date of authorisation: 08/01/2018, , Revision: 8, Authorised, Last updated: 14/06/2022
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Human medicine European public assessment report (EPAR): Vidaza (updated)

azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008, , Revision: 25, Authorised, Last updated: 14/06/2022
List item

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: 10, Authorised, Last updated: 13/06/2022
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Human medicine European public assessment report (EPAR): Enhertu (updated)

trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021, , , Revision: 5, Authorised, Last updated: 13/06/2022
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Human medicine European public assessment report (EPAR): Minjuvi (updated)

Tafasitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 26/08/2021, , , , Revision: 3, Authorised, Last updated: 13/06/2022
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Human medicine European public assessment report (EPAR): Jemperli (updated)

dostarlimab, Endometrial Neoplasms
Date of authorisation: 21/04/2021, , , Revision: 3, Authorised, Last updated: 10/06/2022
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Human medicine European public assessment report (EPAR): Orgovyx (updated)

relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022, , Revision: 2, Authorised, Last updated: 10/06/2022
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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: 4, Authorised, Last updated: 10/06/2022
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Human medicine European public assessment report (EPAR): Palynziq (updated)

Pegvaliase, Phenylketonurias
Date of authorisation: 03/05/2019, , , Revision: 6, Authorised, Last updated: 10/06/2022
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Human medicine European public assessment report (EPAR): Nexpovio (updated)

Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021, , , Revision: 2, Authorised, Last updated: 10/06/2022
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Human medicine European public assessment report (EPAR): Gavreto (updated)

pralsetinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 18/11/2021, , , Revision: 3, Authorised, Last updated: 10/06/2022
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Human medicine European public assessment report (EPAR): Veltassa (updated)

patiromer sorbitex calcium, Hyperkalemia
Date of authorisation: 19/07/2017, , Revision: 5, Authorised, Last updated: 09/06/2022
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Human medicine European public assessment report (EPAR): Cabometyx (updated)

cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016, , Revision: 14, Authorised, Last updated: 09/06/2022
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Human medicine European public assessment report (EPAR): Rozlytrek (updated)

Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020, , , Revision: 3, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Lemtrada (updated)

alemtuzumab, Multiple Sclerosis
Date of authorisation: 12/09/2013, , Revision: 18, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Flixabi (updated)

infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Arthritis, Rheumatoid; Crohn Disease; Psoriasis
Date of authorisation: 26/05/2016, , Revision: 21, Authorised, Last updated: 08/06/2022
List item

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: 8, Authorised, Last updated: 08/06/2022
List item

Human medicine European public assessment report (EPAR): Rinvoq (updated)

upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019, , Revision: 10, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Tegsedi (updated)

inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018, , , , Revision: 10, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) (updated)

split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 10/10/2009, , Revision: 11, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Polivy (updated)

polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020, , , , Revision: 4, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Quviviq (updated)

daridorexant hydrochloride, Sleep Initiation and Maintenance Disorders
Date of authorisation: 29/04/2022, , Revision: 1, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Deltyba (updated)

Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013, , , , Revision: 20, Authorised, Last updated: 07/06/2022
List item

Human medicine European public assessment report (EPAR): Daxas (updated)

roflumilast, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 05/07/2010, , Revision: 18, Authorised, Last updated: 07/06/2022
List item

Human medicine European public assessment report (EPAR): Vydura (updated)

Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022, , Revision: 1, Authorised, Last updated: 07/06/2022