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Human medicine European public assessment report (EPAR): Vabysmo
Faricimab, Wet Macular Degeneration; Macular Edema; Diabetes Complications
Date of authorisation: 15/09/2022,, Authorised, Last updated: 13/10/2022
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Human medicine European public assessment report (EPAR): Thalidomide Lipomed
Thalidomide, Multiple Myeloma
Date of authorisation: 19/09/2022, Authorised, Last updated: 20/10/2022 -
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Human medicine European public assessment report (EPAR): Lupkynis
Voclosporin, Lupus Nephritis
Date of authorisation: 15/09/2022,, Authorised, Last updated: 20/09/2022
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Human medicine European public assessment report (EPAR): Mounjaro
Tirzepatide, Diabetes Mellitus, Type 2
Date of authorisation: 15/09/2022, Authorised, Last updated: 25/11/2022 -
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Human medicine European public assessment report (EPAR): Lutetium (177Lu) chloride Billev (previously Illuzyce)
lutetium (177Lu) chloride, Radionuclide Imaging
Date of authorisation: 15/09/2022, Revision: 1, Authorised, Last updated: 08/12/2022 -
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Human medicine European public assessment report (EPAR): Tezspire
tezepelumab, Asthma
Date of authorisation: 19/09/2022,, Revision: 1, Authorised, Last updated: 09/11/2022
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Human medicine European public assessment report (EPAR): Amvuttra (updated)
vutrisiran sodium, Amyloid Neuropathies, Familial
Date of authorisation: 15/09/2022,,
, Revision: 1, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Opdualag
nivolumab, Relatlimab, Melanoma
Date of authorisation: 15/09/2022,, Authorised, Last updated: 17/10/2022
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Human medicine European public assessment report (EPAR): Celdoxome pegylated liposomal (updated)
doxorubicin hydrochloride, Breast Neoplasms; Ovarian Neoplasms; Multiple Myeloma; Sarcoma, Kaposi
Date of authorisation: 15/09/2022, Authorised, Last updated: 31/01/2023 -
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Human medicine European public assessment report (EPAR): Tecvayli
Teclistamab, Multiple Myeloma
Date of authorisation: 23/08/2022,,
, Authorised, Last updated: 20/10/2022
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Human medicine European public assessment report (EPAR): Vyvgart
Efgartigimod alfa, Myasthenia Gravis
Date of authorisation: 10/08/2022,,
, Revision: 2, Authorised, Last updated: 22/11/2022
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Human medicine European public assessment report (EPAR): Sunlenca
Lenacapavir sodium, HIV Infections
Date of authorisation: 17/08/2022,, Authorised, Last updated: 25/08/2022
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Human medicine European public assessment report (EPAR): Roctavian
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,,
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, Revision: 1, Authorised, Last updated: 09/11/2022
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva
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): Scemblix
asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022,,
, Revision: 1, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Vegzelma
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 17/08/2022,,
, Revision: 1, Authorised, Last updated: 26/09/2022
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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): Ganirelix Gedeon Richter
ganirelix acetate, Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
Date of authorisation: 15/07/2022,, Authorised, Last updated: 20/07/2022
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Human medicine European public assessment report (EPAR): Sugammadex Fresenius Kabi
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 15/07/2022,, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Upstaza
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,,
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, Revision: 2, Authorised, Last updated: 30/09/2022
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Human medicine European public assessment report (EPAR): Xenpozyme
Olipudase alfa, Acid sphingomyelinase deficiency (ASMD) type A/B or type B
Date of authorisation: 24/06/2022,,
, Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Ertapenem SUN
ertapenem sodium, Bacterial Infections
Date of authorisation: 15/07/2022,, Authorised, Last updated: 21/11/2022
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Human medicine European public assessment report (EPAR): Kinpeygo
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,,
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, Revision: 2, Authorised, Last updated: 23/11/2022
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Human medicine European public assessment report (EPAR): Cevenfacta
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): Zokinvy
Lonafarnib, Progeria; Laminopathies
Date of authorisation: 18/07/2022,,
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, Authorised, Last updated: 01/08/2022