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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): 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
quizartinib Overview Vanflyta is a cancer medicine used to treat adults … myeloid leukaemia (AML), a cancer of the white blood cells … given to those patients whose cancer cells have a particular change … -
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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
treat the following types of cancer: early breast cancer (when the cancer has spread within the breast … treat the following types of cancer: • early breast cancer (when the cancer has spread within the breast … -
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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
a side effect of certain cancer treatments and Tyenne is … side effect of certain cancer treatments and Tyenne is … -
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Human medicine European public assessment report (EPAR): Pylclari (updated)
Piflufolastat (18F), Prostatic Neoplasms
Date of authorisation: 24/07/2023,, Revision: 1, Authorised, Last updated: 30/11/2023
Male Urogenital Neoplasms Neoplasms Cancer Genital Diseases, Male Genital … used in adults with prostate cancer to detect prostate cancer cells with a protein called … find out whether prostate cancer has spread to lymph nodes … -
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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): Qaialdo
spironolactone, Edema; Heart Failure; Liver Cirrhosis; Ascites; Nephrotic Syndrome; Hyperaldosteronism; Essential Hypertension
Date of authorisation: 26/05/2023, Authorised, Last updated: 25/07/2023ascites (ascites caused by cancer cells spreading to the organs … ascites (ascites caused by cancer cells spreading to the organs … -
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Human medicine European public assessment report (EPAR): Camzyos
Mavacamten, Cardiomyopathy, Hypertrophic
Date of authorisation: 26/06/2023,, Revision: 1, Authorised, Last updated: 07/08/2023
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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
Orserdu Cancer Neoplasms Skin and Connective … elacestrant Overview Orserdu is a cancer medicine used to treat postmenopausal … women and men with breast cancer that is locally advanced … -
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Human medicine European public assessment report (EPAR): Lytgobi
Futibatinib, Cholangiocarcinoma
Date of authorisation: 04/07/2023,, 
, Revision: 1, Authorised, Last updated: 19/10/2023
Histologic Type Neoplasms Cancer Cholangiocarcinoma … futibatinib Overview Lytgobi is a cancer medicine used to treat adults … cholangiocarcinoma (biliary tract cancer or cancer of the bile ducts) when the cancer cells have an abnormal form … -
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Human medicine European public assessment report (EPAR): Columvi
Glofitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 07/07/2023,, , , Authorised, Last updated: 18/07/2023
Non-Hodgkin Lymphoma Neoplasms Cancer Lymphoproliferative Disorders Lymphatic … glofitamab Overview Columvi is a cancer medicine used to treat adults … treat adults with a blood cancer called diffuse large B-cell … -
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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
medicines or to patients who have cancer (unless it is a skin cancer called basal cell carcinoma … medicines or to patients who have cancer (unless it is a skin cancer called basal cell carcinoma … -
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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
Tevimbra Cancer Neoplasms Neoplasms, Glandular … tislelizumab Overview Tevimbra is a cancer medicine used to treat adults … with squamous oesophageal cancer cancer of the oesophagus, the passage … -
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Human medicine European public assessment report (EPAR): Tepkinly
epcoritamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/09/2023,, , , Authorised, Last updated: 05/10/2023
Tepkinly Cancer Neoplasms Lymphoma Lymphoma … epcoritamab Overview Tepkinly is a cancer medicine used to treat adults … treat adults with a blood cancer called diffuse large B-cell … -
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Human medicine European public assessment report (EPAR): Talvey (updated)
talquetamab, Multiple Myeloma
Date of authorisation: 21/08/2023,, , , Revision: 1, Authorised, Last updated: 24/11/2023
Talvey Cancer Neoplasms Neoplasms, Plasma … talquetamab Overview Talvey is a cancer medicine used to treat adults … with multiple myeloma (a cancer of the bone marrow) when the cancer has come back (relapsed … -
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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
heart or blood vessels), cancer, neurotoxicity (damage to … heart or blood vessels), cancer, neurotoxicity (damage to … -
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Human medicine European public assessment report (EPAR): Inaqovi (updated)
cedazuridine, decitabine, Leukemia, Myeloid
Date of authorisation: 15/09/2023,, Authorised, Last updated: 30/11/2023
Inaqovi Cancer Neoplasms Leukemia Leukemia … cedazuridinedecitabine Overview Inaqovi is a cancer medicine used in adults to … leukaemia (AML), a type of cancer affecting the white blood … -
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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
Enrylaze Cancer Neoplasms Leukemia Leukemia … crisantaspase Overview Enrylaze is a cancer medicine used in adults and … lymphoblastic lymphoma (LBL), cancers of white blood cells called … -
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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
Degarelix Accord Cancer Neoplasms Urogenital Neoplasms Genital … a medicine used to treat cancer of the prostate (a gland … system) in adult men when the cancer is hormone-dependent, which … -
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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): 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): 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): Arexvy
Respiratory Syncytial Virus recombinant glycoprotein F stabilised in the pre-fusion conformation (RSVPreF3) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology, Respiratory Syncytial Virus Infections
Date of authorisation: 06/06/2023, Authorised, Last updated: 22/06/2023