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2071 results
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Human medicine European public assessment report (EPAR): Sylvant (updated)
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,
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, Revision: 12, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Hemangiol (updated)
propranolol hydrochloride, Hemangioma
Date of authorisation: 23/04/2014, Revision: 6, Authorised, Last updated: 09/02/2023 -
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Human medicine European public assessment report (EPAR): Epclusa (updated)
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, Revision: 19, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Harvoni (updated)
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, Revision: 27, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Sovaldi (updated)
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,, Revision: 27, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Defitelio (updated)
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,
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, Revision: 14, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Stivarga (updated)
regorafenib, Colorectal Neoplasms
Date of authorisation: 26/08/2013, Revision: 19, Authorised, Last updated: 09/02/2023 -
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 17/07/2015,
, Revision: 15, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Vosevi (updated)
Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic
Date of authorisation: 26/07/2017, Revision: 14, Authorised, Last updated: 09/02/2023 -
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Human medicine European public assessment report (EPAR): Fluenz Tetra (updated)
A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444, Influenza, Human
Date of authorisation: 04/12/2013, Revision: 23, Authorised, Last updated: 09/02/2023 -
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Human medicine European public assessment report (EPAR): Spevigo (updated)
Spesolimab, Psoriasis
Date of authorisation: 09/12/2022,, 
, Authorised, Last updated: 08/02/2023
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Human medicine European public assessment report (EPAR): Fintepla (updated)
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,, , Revision: 4, Authorised, Last updated: 07/02/2023
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Human medicine European public assessment report (EPAR): Lupkynis (updated)
Voclosporin, Lupus Nephritis
Date of authorisation: 15/09/2022,, Revision: 1, Authorised, Last updated: 07/02/2023
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Human medicine European public assessment report (EPAR): Imcivree (updated)
Setmelanotide, Obesity
Date of authorisation: 16/07/2021,, , Revision: 6, Authorised, Last updated: 07/02/2023
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Human medicine European public assessment report (EPAR): Epidyolex (updated)
Cannabidiol, Lennox Gastaut Syndrome; Epilepsies, Myoclonic
Date of authorisation: 19/09/2019,, Revision: 12, Authorised, Last updated: 07/02/2023
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Human medicine European public assessment report (EPAR): Kisqali (updated)
ribociclib succinate, Breast Neoplasms
Date of authorisation: 22/08/2017, Revision: 13, Authorised, Last updated: 07/02/2023 -
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Human medicine European public assessment report (EPAR): Dupixent (updated)
dupilumab, Dermatitis, Atopic
Date of authorisation: 26/09/2017, Revision: 21, Authorised, Last updated: 06/02/2023 -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan (updated)
emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 16/12/2016,, Revision: 12, Authorised, Last updated: 06/02/2023
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Human medicine European public assessment report (EPAR): Flixabi (updated)
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Arthritis, Rheumatoid; Crohn Disease; Psoriasis
Date of authorisation: 26/05/2016,
, Revision: 23, Authorised, Last updated: 06/02/2023
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Human medicine European public assessment report (EPAR): Evrysdi (updated)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,, , Revision: 3, Authorised, Last updated: 06/02/2023
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Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG (updated)
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009,, Revision: 8, Authorised, Last updated: 06/02/2023
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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: 35, Authorised, Last updated: 03/02/2023
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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: 38, Authorised, Last updated: 03/02/2023
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Human medicine European public assessment report (EPAR): Darunavir Krka d.d. (updated)
darunavir, HIV Infections
Date of authorisation: 18/01/2018,, Revision: 8, Withdrawn, Last updated: 03/02/2023
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Human medicine European public assessment report (EPAR): Truvada (updated)
emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 20/02/2005, Revision: 46, Authorised, Last updated: 02/02/2023