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2022 results
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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,
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, Revision: 2, Authorised, Last updated: 30/11/2023
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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 -
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Human medicine European public assessment report (EPAR): Stribild (updated)
elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 24/05/2013, Revision: 25, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Bemrist Breezhaler (updated)
indacaterol, Mometasone furoate, Asthma
Date of authorisation: 30/05/2020, Revision: 5, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Atectura Breezhaler (updated)
indacaterol acetate, Mometasone furoate, Asthma
Date of authorisation: 30/05/2020, Revision: 7, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Lynparza (updated)
Olaparib, Ovarian Neoplasms
Date of authorisation: 16/12/2014, Revision: 19, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): DuoPlavin (updated)
clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 14/03/2010, Revision: 27, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Karvezide (updated)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 16/10/1998, Revision: 44, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Segluromet (updated)
ertugliflozin l-pyroglutamic acid, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 23/03/2018, Revision: 6, Authorised, Last updated: 02/02/2023 -
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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: 17, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Veklury (updated)
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,, Revision: 17, Authorised, Last updated: 02/02/2023
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Human medicine European public assessment report (EPAR): Praluent (updated)
Alirocumab, Dyslipidemias
Date of authorisation: 23/09/2015, Revision: 19, Authorised, Last updated: 02/02/2023