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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): Zynquista (updated)

Sotagliflozin, Diabetes Mellitus, Type 1
Date of authorisation: 26/04/2019, , Revision: 3, Withdrawn, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Lokelma (updated)

sodium zirconium cyclosilicate, Hyperkalemia
Date of authorisation: 22/03/2018, , Revision: 6, 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, , , , , 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, , , , Revision: 23, Authorised, Last updated: 12/08/2022
List item

Human medicine European public assessment report (EPAR): Veklury (updated)

remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020, , Revision: 12, Authorised, Last updated: 12/08/2022
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Human medicine European public assessment report (EPAR): Alecensa (updated)

alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017, , Revision: 12, Authorised, Last updated: 11/08/2022
List item

Human medicine European public assessment report (EPAR): Grasustek (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019, , , Revision: 3, Authorised, Last updated: 10/08/2022
List item

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
List item

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
List item

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
List item

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): Zejula (updated)

Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017, , , Revision: 18, Authorised, Last updated: 09/08/2022
List item

Human medicine European public assessment report (EPAR): Kaftrio (updated)

ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020, , , Revision: 8, Authorised, Last updated: 09/08/2022
List item

Human medicine European public assessment report (EPAR): Rinvoq (updated)

upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019, , Revision: 11, Authorised, Last updated: 05/08/2022
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Human medicine European public assessment report (EPAR): Braftovi (updated)

Encorafenib, Melanoma; Colorectal Neoplasms
Date of authorisation: 19/09/2018, , Revision: 10, Authorised, Last updated: 05/08/2022
List item

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
List item

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): Ervebo (updated)

recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola
Date of authorisation: 11/11/2019, , Revision: 7, Authorised, Last updated: 04/08/2022
List item

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
List item

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): Nexviadyme (updated)

Avalglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 24/06/2022, , Authorised, Last updated: 02/08/2022
List item

Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva (updated)

SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022, , Revision: 1, Authorised, Last updated: 02/08/2022