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Medicine
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Human medicine European public assessment report (EPAR): Vemlidy (updated)
tenofovir alafenamide fumarate, Hepatitis B
Date of authorisation: 09/01/2017, Revision: 16, Authorised, Last updated: 31/05/2023 -
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Human medicine European public assessment report (EPAR): Dabigatran Etexilate Accord (updated)
Dabigatran etexilate mesilate, Venous Thromboembolism; Arthroplasty, Replacement
Date of authorisation: 26/05/2023,
, Authorised, Last updated: 31/05/2023
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Human medicine European public assessment report (EPAR): Epysqli (updated)
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 26/05/2023,
, 
, Authorised, Last updated: 31/05/2023
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Human medicine European public assessment report (EPAR): Pergoveris (updated)
follitropin alfa, lutropin alfa, Infertility, Female
Date of authorisation: 25/06/2007, Revision: 15, Authorised, Last updated: 31/05/2023 -
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,
, , Revision: 37, Authorised, Last updated: 31/05/2023
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (updated)
efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017,, Revision: 15, Authorised, Last updated: 30/05/2023
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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: 59, Authorised, Last updated: 30/05/2023 -
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Human medicine European public assessment report (EPAR): Ebymect (updated)
dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2015, Revision: 19, Authorised, Last updated: 30/05/2023 -
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Human medicine European public assessment report (EPAR): Edistride (updated)
dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
Date of authorisation: 09/11/2015, Revision: 22, Authorised, Last updated: 30/05/2023 -
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Human medicine European public assessment report (EPAR): Forxiga (updated)
dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2; Heart Failure, Systolic; Heart Failure; Renal Insufficiency, Chronic
Date of authorisation: 11/11/2012, Revision: 28, Authorised, Last updated: 30/05/2023 -
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Human medicine European public assessment report (EPAR): Xigduo (updated)
metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 16/01/2014, Revision: 21, Authorised, Last updated: 30/05/2023 -
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Human medicine European public assessment report (EPAR): Qtern (updated)
Saxagliptin, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2; Diabetes Mellitus; Nutritional and Metabolic Diseases; Metabolic Diseases; Glucose Metabolism Disorders
Date of authorisation: 15/07/2016, Revision: 11, Authorised, Last updated: 30/05/2023 -
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Human medicine European public assessment report (EPAR): Komboglyze (updated)
metformin hydrochloride, saxagliptin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 24/11/2011, Revision: 20, Authorised, Last updated: 30/05/2023 -
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Human medicine European public assessment report (EPAR): Remsima (updated)
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,, Revision: 35, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan (updated)
sitagliptin hydrochloride monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022,, Revision: 2, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Lonsurf (updated)
trifluridine, tipiracil hydrochloride, Colorectal Neoplasms
Date of authorisation: 25/04/2016, Revision: 8, Authorised, Last updated: 30/05/2023 -
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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: 7, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Rivaroxaban Accord (updated)
rivaroxaban, Acute Coronary Syndrome; Coronary Artery Disease; Peripheral Arterial Disease; Venous Thromboembolism; Stroke; Atrial Fibrillation; Pulmonary Embolism
Date of authorisation: 16/11/2020,, Revision: 3, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Invokana (updated)
canagliflozin, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2013, Revision: 22, Authorised, Last updated: 30/05/2023 -
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Human medicine European public assessment report (EPAR): Okedi (updated)
Risperidone, Schizophrenia
Date of authorisation: 14/02/2022, Revision: 2, Authorised, Last updated: 30/05/2023 -
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Human medicine European public assessment report (EPAR): Ondexxya (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, 
, Revision: 15, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Jyseleca (updated)
filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020,, , Revision: 9, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, 
, , Revision: 11, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Rivaroxaban Mylan (updated)
rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021,, Revision: 3, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Pombiliti (updated)
Cipaglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 20/03/2023,, Authorised, Last updated: 30/05/2023