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Human medicine European public assessment report (EPAR): Zirabev (updated)
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,,
, Revision: 13, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Oyavas (updated)
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: 26/03/2021,,
, Revision: 6, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Talmanco (previously Tadalafil Generics) (updated)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 09/01/2017,, Revision: 8, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Zokinvy (updated)
Lonafarnib, Progeria; Laminopathies
Date of authorisation: 18/07/2022,,
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, Revision: 2, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS CoV-2 (Original) recombinant spike protein, SARS-CoV-2 (Omicron XBB.1.5) recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, Revision: 11, Authorised, Last updated: 08/11/2023
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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,, Revision: 1, Authorised, Last updated: 08/11/2023
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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): Xospata (updated)
gilteritinib fumarate, Leukemia, Myeloid, Acute
Date of authorisation: 24/10/2019,,
, Revision: 5, Authorised, Last updated: 07/11/2023
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Human medicine European public assessment report (EPAR): PreHevbri (updated)
hepatitis B surface antigen, Hepatitis B
Date of authorisation: 25/04/2022,, Revision: 2, Authorised, Last updated: 07/11/2023
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Human medicine European public assessment report (EPAR): Refixia (updated)
Nonacog beta pegol, Hemophilia B
Date of authorisation: 02/06/2017,, Revision: 5, Authorised, Last updated: 06/11/2023
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Human medicine European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene) (updated)
Pomalidomide, Multiple Myeloma
Date of authorisation: 05/08/2013,, Revision: 24, Authorised, Last updated: 06/11/2023
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Human medicine European public assessment report (EPAR): Lojuxta (updated)
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,,
, Revision: 18, Authorised, Last updated: 06/11/2023
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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: 4, Authorised, Last updated: 06/11/2023
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Human medicine European public assessment report (EPAR): Tavneos (updated)
Avacopan, Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 11/01/2022,,
, Revision: 4, Authorised, Last updated: 03/11/2023
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Human medicine European public assessment report (EPAR): Calquence (updated)
Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 05/11/2020,, Revision: 7, Authorised, Last updated: 03/11/2023
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Human medicine European public assessment report (EPAR): Venclyxto (updated)
Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 04/12/2016,, Revision: 16, Authorised, Last updated: 31/10/2023
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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: 45, Authorised, Last updated: 31/10/2023
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Human medicine European public assessment report (EPAR): Minjuvi (updated)
Tafasitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 26/08/2021,,
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, Revision: 4, Authorised, Last updated: 31/10/2023
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Human medicine European public assessment report (EPAR): Benlysta (updated)
belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011,, Revision: 31, Authorised, Last updated: 31/10/2023
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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: 6, Authorised, Last updated: 30/10/2023
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Human medicine European public assessment report (EPAR): Yescarta
Axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,,
, Revision: 12, Authorised, Last updated: 30/10/2023
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Human medicine European public assessment report (EPAR): Xofigo
radium (223Ra) dichloride, Prostatic Neoplasms
Date of authorisation: 13/11/2013,, Revision: 14, Authorised, Last updated: 30/10/2023
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Human medicine European public assessment report (EPAR): Tecvayli
Teclistamab, Multiple Myeloma
Date of authorisation: 23/08/2022,,
, Revision: 2, Authorised, Last updated: 30/10/2023
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Human medicine European public assessment report (EPAR): Raxone
idebenone, Optic Atrophy, Hereditary, Leber
Date of authorisation: 08/09/2015,,
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, Revision: 9, Authorised, Last updated: 30/10/2023
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Human medicine European public assessment report (EPAR): Adtralza
Tralokinumab, Dermatitis, Atopic
Date of authorisation: 17/06/2021,, Revision: 4, Authorised, Last updated: 30/10/2023