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Human medicine European public assessment report (EPAR): Zoonotic Influenza Vaccine Seqirus
zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23), Influenza A Virus, H5N1 Subtype Authorised, Last updated: 14/09/2023 -
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Human medicine European public assessment report (EPAR): Vanflyta (updated)
Quizartinib dihydrochloride, Leukemia, Myeloid
Date of authorisation: 06/11/2023,, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Aqumeldi (updated)
Enalapril (maleate), Heart Failure
Date of authorisation: 15/11/2023, Authorised, Last updated: 22/11/2023 -
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Human medicine European public assessment report (EPAR): Herwenda (updated)
trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 15/11/2023,,
, Authorised, Last updated: 23/11/2023
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Human medicine European public assessment report (EPAR): Ebglyss (new)
Lebrikizumab, Dermatitis, Atopic
Date of authorisation: 16/11/2023,, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Enerzair Breezhaler
indacaterol, Glycopyrronium bromide, mometasone, Asthma
Date of authorisation: 03/07/2020, Revision: 6, Authorised, Last updated: 16/10/2023 -
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Human medicine European public assessment report (EPAR): Artesunate Amivas (updated)
artesunate, Malaria
Date of authorisation: 22/11/2021,,
, Revision: 4, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Azilect
rasagiline, Parkinson Disease
Date of authorisation: 21/02/2005, Revision: 23, Authorised, Last updated: 18/08/2023 -
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Human medicine European public assessment report (EPAR): Apretude
Cabotegravir, HIV Infections
Date of authorisation: 15/09/2023, Authorised, Last updated: 20/09/2023 -
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Human medicine European public assessment report (EPAR): Yesafili
aflibercept, Macular Edema; Retinal Vein Occlusion; Diabetic Retinopathy; Myopia, Degenerative; Diabetes Complications
Date of authorisation: 15/09/2023,,
, Authorised, Last updated: 03/10/2023
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Human medicine European public assessment report (EPAR): Enrylaze
crisantaspase, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 15/09/2023,, Authorised, Last updated: 05/10/2023
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Human medicine European public assessment report (EPAR): Tepkinly
epcoritamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/09/2023,,
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, Authorised, Last updated: 05/10/2023
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Human medicine European public assessment report (EPAR): Tevimbra
Tislelizumab, Esophageal Squamous Cell Carcinoma
Date of authorisation: 15/09/2023,, Authorised, Last updated: 10/10/2023
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Human medicine European public assessment report (EPAR): Lyfnua
Gefapixant, Cough
Date of authorisation: 15/09/2023,, Authorised, Last updated: 10/10/2023
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Human medicine European public assessment report (EPAR): Litfulo
ritlecitinib tosilate, Alopecia Areata
Date of authorisation: 15/09/2023,, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Abrysvo
Respiratory syncytial virus, subgroup A, stabilized prefusion F protein / Respiratory syncytial virus, subgroup B, stabilized prefusion F protein, Respiratory Syncytial Virus Infections
Date of authorisation: 23/08/2023,,
, Authorised, Last updated: 26/09/2023
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Human medicine European public assessment report (EPAR): Tyenne
tocilizumab, Arthritis, Rheumatoid; Cytokine Release Syndrome; Arthritis, Juvenile Rheumatoid; COVID-19 virus infection; Giant Cell Arteritis
Date of authorisation: 15/09/2023,, Authorised, Last updated: 02/10/2023
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Human medicine European public assessment report (EPAR): Degarelix Accord (updated)
degarelix acetate, Prostatic Neoplasms
Date of authorisation: 29/09/2023,, Authorised, Last updated: 08/11/2023
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Human medicine European public assessment report (EPAR): Tyruko (updated)
natalizumab, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 22/09/2023,,
, Revision: 1, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Talvey (updated)
talquetamab, Multiple Myeloma
Date of authorisation: 21/08/2023,,
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, Revision: 1, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Orserdu (updated)
elacestrant, Breast Neoplasms
Date of authorisation: 15/09/2023,, Authorised, Last updated: 27/11/2023
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Human medicine European public assessment report (EPAR): Aquipta
atogepant, Migraine Disorders
Date of authorisation: 11/08/2023,, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Briumvi
Ublituximab, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 31/05/2023,, Revision: 01, Authorised, Last updated: 18/10/2023
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Human medicine European public assessment report (EPAR): Sohonos
Palovarotene, Myositis Ossificans
Date of refusal: 17/07/2023,, Refused, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Pylclari
Piflufolastat (18F), Prostatic Neoplasms
Date of authorisation: 24/07/2023,, Authorised, Last updated: 28/07/2023