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Human medicine European public assessment report (EPAR): Velmetia (updated)
sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/07/2008, Revision: 33, Authorised, Last updated: 30/09/2022 -
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Human medicine European public assessment report (EPAR): Ertapenem SUN (updated)
ertapenem sodium, Bacterial Infections
Date of authorisation: 15/07/2022,
, Authorised, Last updated: 30/09/2022
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Human medicine European public assessment report (EPAR): Lyxumia (updated)
lixisenatide, Diabetes Mellitus, Type 2
Date of authorisation: 31/01/2013, Revision: 16, Authorised, Last updated: 30/09/2022 -
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Human medicine European public assessment report (EPAR): Amlodipine / Valsartan Mylan (updated)
Amlodipine besilate, valsartan, Hypertension
Date of authorisation: 22/03/2016,, Revision: 10, Authorised, Last updated: 30/09/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Mylan (updated)
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 2, Authorised, Last updated: 30/09/2022
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Human medicine European public assessment report (EPAR): Ogivri (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 12/12/2018,
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, Revision: 9, Authorised, Last updated: 30/09/2022
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Human medicine European public assessment report (EPAR): Upstaza (updated)
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,, 
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, Revision: 2, Authorised, Last updated: 30/09/2022
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Human medicine European public assessment report (EPAR): Nulibry (updated)
fosdenopterin hydrobromide dihydrate, Metal Metabolism, Inborn Errors
Date of authorisation: 15/09/2022,, , Authorised, Last updated: 30/09/2022
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA 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: 21/12/2020,
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, Revision: 30, Authorised, Last updated: 30/09/2022
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Human medicine European public assessment report (EPAR): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) (updated)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 18/01/2007, Revision: 33, Authorised, Last updated: 28/09/2022 -
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Human medicine European public assessment report (EPAR): Myozyme (updated)
alglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 28/03/2006, Revision: 20, Authorised, Last updated: 28/09/2022 -
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Human medicine European public assessment report (EPAR): Roctavian (updated)
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,, , , Authorised, Last updated: 28/09/2022
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Human medicine European public assessment report (EPAR): Xeljanz (updated)
Tofacitinib, Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,
Date of refusal: 25/04/2013, Revision: 26, Authorised, Last updated: 28/09/2022 -
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Human medicine European public assessment report (EPAR): Fasenra (updated)
benralizumab, Asthma
Date of authorisation: 08/01/2018, Revision: 9, Authorised, Last updated: 28/09/2022 -
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Human medicine European public assessment report (EPAR): Vyvgart (updated)
Efgartigimod alfa, Myasthenia Gravis
Date of authorisation: 10/08/2022,, , Revision: 1, Authorised, Last updated: 28/09/2022
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Human medicine European public assessment report (EPAR): Imcivree (updated)
Setmelanotide, Obesity
Date of authorisation: 16/07/2021,, , Revision: 4, Authorised, Last updated: 28/09/2022
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Human medicine European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop) (updated)
irbesartan, Hypertension
Date of authorisation: 19/01/2007, Revision: 28, Authorised, Last updated: 28/09/2022 -
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Human medicine European public assessment report (EPAR): Obiltoxaximab SFL (updated)
Obiltoxaximab, Anthrax
Date of authorisation: 18/11/2020,, , , Revision: 2, Authorised, Last updated: 28/09/2022
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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: 29, Authorised, Last updated: 28/09/2022
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Human medicine European public assessment report (EPAR): Ozempic (updated)
semaglutide, Diabetes Mellitus
Date of authorisation: 08/02/2018,, Revision: 9, Authorised, Last updated: 28/09/2022
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Human medicine European public assessment report (EPAR): Skilarence (updated)
dimethyl fumarate, Psoriasis
Date of authorisation: 23/06/2017, Revision: 11, Authorised, Last updated: 27/09/2022 -
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Human medicine European public assessment report (EPAR): Lemtrada (updated)
alemtuzumab, Multiple Sclerosis
Date of authorisation: 12/09/2013,, Revision: 20, Authorised, Last updated: 27/09/2022
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Human medicine European public assessment report (EPAR): Tukysa (updated)
Tucatinib, Breast Neoplasms; Neoplasm Metastasis
Date of authorisation: 11/02/2021,, Revision: 2, Authorised, Last updated: 27/09/2022
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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: 42, Authorised, Last updated: 27/09/2022 -
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Human medicine European public assessment report (EPAR): Hemlibra (updated)
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, 
, Revision: 12, Authorised, Last updated: 27/09/2022