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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,
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, Revision: 34, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Bimzelx (updated)
bimekizumab, Psoriasis
Date of authorisation: 20/08/2021,, Revision: 2, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Piqray (updated)
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,, Revision: 6, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Nerlynx (updated)
neratinib, Breast Neoplasms
Date of authorisation: 31/08/2018,, Revision: 12, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Cabometyx (updated)
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,
, Revision: 15, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Pyrukynd (updated)
mitapivat sulfate, Genetic Diseases, Inborn; Anemia, Hemolytic
Date of authorisation: 09/11/2022,, 
, Authorised, Last updated: 05/12/2022
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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: 13, Authorised, Last updated: 05/12/2022
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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: 4, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Pemazyre (updated)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,, , 
, Revision: 4, Authorised, Last updated: 02/12/2022
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Human medicine European public assessment report (EPAR): Tecartus (updated)
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,, , , Revision: 3, Authorised, Last updated: 02/12/2022
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Human medicine European public assessment report (EPAR): Livtencity (updated)
Maribavir, Cytomegalovirus Infections
Date of authorisation: 09/11/2022,, , Authorised, Last updated: 01/12/2022
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Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , , Revision: 14, Authorised, Last updated: 30/11/2022
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Human medicine European public assessment report (EPAR): Kevzara (updated)
sarilumab, Arthritis, Rheumatoid
Date of authorisation: 23/06/2017,, Revision: 9, Authorised, Last updated: 30/11/2022
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Human medicine European public assessment report (EPAR): Uplizna (updated)
Inebilizumab, Neuromyelitis Optica
Date of authorisation: 25/04/2022,, Revision: 1, Authorised, Last updated: 30/11/2022
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Human medicine European public assessment report (EPAR): VidPrevtyn Beta (updated)
SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain), COVID-19 virus infection
Date of authorisation: 10/11/2022,, Authorised, Last updated: 30/11/2022
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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: 25, Authorised, Last updated: 30/11/2022
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Human medicine European public assessment report (EPAR): Zeposia (updated)
ozanimod hydrochloride, Multiple Sclerosis, Relapsing-Remitting; Colitis, Ulcerative
Date of authorisation: 20/05/2020,, Revision: 4, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Rozlytrek (updated)
Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,, , Revision: 5, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Lumykras (updated)
sotorasib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/01/2022,, , Revision: 1, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Cevenfacta (updated)
Eptacog beta (activated), Hemophilia A; Hemophilia B
Date of authorisation: 15/07/2022,, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Ximluci (updated)
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 09/11/2022,, , Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Recarbrio (updated)
imipenem monohydrate, cilastatin sodium, relebactam monohydrate, Gram-Negative Bacterial Infections
Date of authorisation: 13/02/2020,, Revision: 5, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Tagrisso (updated)
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, Revision: 17, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Vaxneuvance (updated)
pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections
Date of authorisation: 13/12/2021,, Revision: 3, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Biktarvy (updated)
bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections
Date of authorisation: 21/06/2018,, Revision: 14, Authorised, Last updated: 28/11/2022