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Medicine type Accelerated assessment Remove Accelerated assessment filter Conditional approval Remove Conditional approval filter Generic Remove Generic filter Additional monitoring Remove Additional monitoring filter Biosimilar Remove Biosimilar filter

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

insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018, , Revision: 10, Authorised, Last updated: 01/12/2023
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Human medicine European public assessment report (EPAR): Ogivri (updated)

trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 12/12/2018, , Revision: 11, Authorised, Last updated: 01/12/2023
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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle) (updated)

insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021, , , Revision: 4, Authorised, Last updated: 01/12/2023
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Human medicine European public assessment report (EPAR): Hulio (updated)

adalimumab, Hidradenitis Suppurativa; Psoriasis; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Arthritis, Psoriatic
Date of authorisation: 17/09/2018, , Revision: 16, Authorised, Last updated: 01/12/2023
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)

Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020, , , Revision: 9, Authorised, Last updated: 01/12/2023
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva (updated)

COVID-19 vaccine (inactivated, adjuvanted, adsorbed), COVID-19 virus infection
Date of authorisation: 24/06/2022, , Revision: 6, Withdrawn, Last updated: 01/12/2023
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Human medicine European public assessment report (EPAR): Ocaliva (updated)

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , Revision: 17, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Rubraca (updated)

rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018, , , Revision: 15, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Kalydeco (updated)

ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012, , Revision: 38, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Inaqovi (updated)

cedazuridine, decitabine, Leukemia, Myeloid
Date of authorisation: 15/09/2023, , Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Yuflyma (updated)

adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 11/02/2021, , Revision: 12, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Soliris (updated)

Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007, , , Revision: 36, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Abevmy (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: 21/04/2021, , , Revision: 7, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Evusheld (updated)

tixagevimab, cilgavimab, COVID-19 virus infection
Date of authorisation: 25/03/2022, , Revision: 6, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Pylclari (updated)

Piflufolastat (18F), Prostatic Neoplasms
Date of authorisation: 24/07/2023, , Revision: 1, Authorised, Last updated: 30/11/2023
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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): 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): 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): 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): 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): 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