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Medicine
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Human medicine European public assessment report (EPAR): Orladeyo (updated)
berotralstat dihydrochloride, Angioedemas, Hereditary
Date of authorisation: 30/04/2021, Revision: 5, Authorised, Last updated: 01/12/2023 -
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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): Adcetris (updated)
Brentuximab vedotin, Lymphoma, Non-Hodgkin; Hodgkin Disease
Date of authorisation: 25/10/2012,, Revision: 35, Authorised, Last updated: 01/12/2023
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Human medicine European public assessment report (EPAR): Otezla (updated)
apremilast, Arthritis, Psoriatic; Psoriasis
Date of authorisation: 15/01/2015, Revision: 21, 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): Plavix (updated)
clopidogrel hydrogen sulfate, Stroke; Peripheral Vascular Diseases; Atrial Fibrillation; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 15/07/1998, Revision: 50, Authorised, Last updated: 01/12/2023 -
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Human medicine European public assessment report (EPAR): Cialis (updated)
tadalafil, Erectile Dysfunction
Date of authorisation: 12/11/2002, Revision: 32, Authorised, Last updated: 01/12/2023 -
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Human medicine European public assessment report (EPAR): Ozawade (updated)
pitolisant, Sleep Apnea, Obstructive
Date of authorisation: 01/09/2021, Revision: 3, Authorised, 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,,
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, Revision: 17, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Praluent (updated)
Alirocumab, Dyslipidemias
Date of authorisation: 23/09/2015, Revision: 21, Authorised, Last updated: 30/11/2023 -
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Human medicine European public assessment report (EPAR): Xelevia (updated)
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2007, Revision: 39, 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): Ventavis (updated)
iloprost, Hypertension, Pulmonary
Date of authorisation: 15/09/2003, Revision: 30, 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): Thalidomide BMS (previously Thalidomide Celgene) (updated)
Thalidomide, Multiple Myeloma
Date of authorisation: 16/04/2008, Revision: 31, 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): Neuraceq (updated)
florbetaben (18F), Radionuclide Imaging; Alzheimer Disease
Date of authorisation: 20/02/2014, Revision: 20, Authorised, Last updated: 30/11/2023