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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, , , 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): 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): 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): 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): Pluvicto (updated)

lutetium (177Lu) vipivotide tetraxetan, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 09/12/2022, , Revision: 1, Authorised, Last updated: 02/02/2023
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Human medicine European public assessment report (EPAR): Caprelsa (updated)

Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012, , Revision: 23, Authorised, Last updated: 01/02/2023
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Human medicine European public assessment report (EPAR): Ninlaro (updated)

ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016, , , , Revision: 15, Authorised, Last updated: 01/02/2023
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Human medicine European public assessment report (EPAR): Mayzent (updated)

Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/01/2020, , Revision: 9, Authorised, Last updated: 31/01/2023
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Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma) (updated)

Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022, , , Revision: 3, Authorised, Last updated: 31/01/2023
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Human medicine European public assessment report (EPAR): Ceplene (updated)

Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008, , , Revision: 12, Authorised, Last updated: 30/01/2023
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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: 4, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Qdenga (updated)

Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated, Dengue virus, serotype 2, live, attenuated, Dengue
Date of authorisation: 05/12/2022, , Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Beyfortus (updated)

nirsevimab,
Date of authorisation: 31/10/2022, , Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Yescarta (updated)

axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018, , , Revision: 11, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Ranivisio (updated)

ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 25/08/2022, , , Revision: 2, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Zynlonta (updated)

loncastuximab tesirine, Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Date of authorisation: 20/12/2022, , , Authorised, Last updated: 26/01/2023
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Human medicine European public assessment report (EPAR): Fingolimod Mylan (updated)

fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 18/08/2021, , Revision: 3, Authorised, Last updated: 26/01/2023
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Human medicine European public assessment report (EPAR): Coagadex (updated)

Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016, , , Revision: 9, Authorised, Last updated: 25/01/2023