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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): 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): 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): 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): 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): Deltyba (updated)
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 21, Authorised, Last updated: 27/09/2022
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Human medicine European public assessment report (EPAR): Rybrevant (updated)
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,, , Revision: 1, Authorised, Last updated: 26/09/2022
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Human medicine European public assessment report (EPAR): Vegzelma (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: 17/08/2022,, , Revision: 1, Authorised, Last updated: 26/09/2022
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Human medicine European public assessment report (EPAR): Atazanavir Mylan (updated)
atazanavir (as sulfate), HIV Infections
Date of authorisation: 22/08/2016,, Revision: 12, Authorised, Last updated: 26/09/2022
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Human medicine European public assessment report (EPAR): Nivestim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 07/06/2010,, Revision: 25, Authorised, Last updated: 26/09/2022
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Human medicine European public assessment report (EPAR): Evkeeza (updated)
Evinacumab, Hypercholesterolemia
Date of authorisation: 17/06/2021,, , Revision: 1, Authorised, Last updated: 23/09/2022
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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: 29, Authorised, Last updated: 23/09/2022
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Human medicine European public assessment report (EPAR): Elzonris (updated)
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,, , , Revision: 5, Authorised, Last updated: 23/09/2022
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Human medicine European public assessment report (EPAR): Posaconazole Accord (updated)
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 6, Authorised, Last updated: 23/09/2022
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Human medicine European public assessment report (EPAR): Libtayo (updated)
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,, , Revision: 12, Authorised, Last updated: 22/09/2022
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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: 12, Authorised, Last updated: 22/09/2022
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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: 9, Authorised, Last updated: 22/09/2022
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Human medicine European public assessment report (EPAR): Kinpeygo (updated)
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,, , , Revision: 1, Authorised, Last updated: 22/09/2022
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 7, Authorised, Last updated: 21/09/2022
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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) (updated)
dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,, , , Revision: 11, Authorised, Last updated: 21/09/2022
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Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously Pemetrexed Hospira) (updated)
pemetrexed disodium, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 19/11/2015,, Revision: 14, Authorised, Last updated: 21/09/2022