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Human medicine European public assessment report (EPAR): Ciambra (updated)
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 02/12/2015,
, Revision: 6, Authorised, Last updated: 17/08/2022
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Human medicine European public assessment report (EPAR): Duloxetine Zentiva (updated)
duloxetine, Neuralgia; Depressive Disorder, Major; Anxiety Disorders; Diabetes Mellitus
Date of authorisation: 20/08/2015,, Revision: 11, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Brineura (updated)
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,
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, Revision: 6, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Exviera (updated)
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, Revision: 25, Authorised, Last updated: 12/08/2022
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,
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, Revision: 23, Authorised, Last updated: 12/08/2022
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, Revision: 33, Authorised, Last updated: 10/08/2022
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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,, , , Revision: 27, Authorised, Last updated: 10/08/2022
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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,, , , Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Pemetrexed medac (updated)
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 26/11/2015,, Revision: 8, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Imvanex (updated)
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013,, , Revision: 21, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Myclausen (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 07/10/2010,, Revision: 15, Authorised, Last updated: 04/08/2022
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Human medicine European public assessment report (EPAR): Elaprase (updated)
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,, , Revision: 24, Authorised, Last updated: 04/08/2022
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Human medicine European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma) (updated)
clopidogrel besilate, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 26, Authorised, Last updated: 03/08/2022
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Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan (updated)
acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 09/01/2020,, Revision: 4, Authorised, Last updated: 02/08/2022
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Human medicine European public assessment report (EPAR): Posaconazole AHCL (updated)
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 4, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Enhertu (updated)
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, , Revision: 6, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Revision: 3, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Elzonris (updated)
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,, , , Revision: 4, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Entecavir Mylan (updated)
entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017,, Revision: 5, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Entecavir Accord (updated)
Entecavir, Hepatitis B, Chronic
Date of authorisation: 25/09/2017,, Revision: 5, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Tigecycline Accord (updated)
Tigecycline, Soft Tissue Infections; Intraabdominal Infections; Bacterial Infections; Skin Diseases, Infectious
Date of authorisation: 17/04/2020,, Revision: 4, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,, , , Revision: 11, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Amversio (updated)
betaine, Homocystinuria
Date of authorisation: 05/05/2022,, , Authorised, Last updated: 28/07/2022
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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: 28/07/2022
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen) (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , , Revision: 22, Authorised, Last updated: 28/07/2022