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Human medicine European public assessment report (EPAR): Abecma
idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021,,
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, Revision: 5, Authorised, Last updated: 21/12/2022
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Human medicine European public assessment report (EPAR): Abevmy
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: 21/04/2021,,
, Revision: 5, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,,
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, Revision: 3, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Adcetris (updated)
Brentuximab vedotin, Lymphoma, Non-Hodgkin; Hodgkin Disease
Date of authorisation: 25/10/2012,, Revision: 34, Authorised, Last updated: 13/03/2023
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Human medicine European public assessment report (EPAR): Adtralza
Tralokinumab, Dermatitis, Atopic
Date of authorisation: 17/06/2021,, Revision: 2, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Adynovi
rurioctocog alfa pegol, Hemophilia A
Date of authorisation: 08/01/2018,, Revision: 8, Authorised, Last updated: 17/11/2022
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Human medicine European public assessment report (EPAR): Aimovig (updated)
erenumab, Migraine Disorders
Date of authorisation: 26/07/2018,, Revision: 9, Authorised, Last updated: 02/03/2023
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Human medicine European public assessment report (EPAR): Ajovy
fremanezumab, Migraine Disorders
Date of authorisation: 28/03/2019,, Revision: 8, Authorised, Last updated: 07/06/2022
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Human medicine European public assessment report (EPAR): Alecensa (updated)
alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017,, Revision: 14, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Alofisel
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,,
, Revision: 9, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Alprolix
eftrenonacog alfa, Hemophilia B
Date of authorisation: 12/05/2016,, Revision: 8, Authorised, Last updated: 04/11/2021
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Human medicine European public assessment report (EPAR): Alunbrig
brigatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 22/11/2018,, Revision: 8, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,,
, Revision: 4, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Amglidia
glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018,, Revision: 5, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Amsparity
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 13/02/2020,,
, Revision: 4, Authorised, Last updated: 29/10/2021
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Human medicine European public assessment report (EPAR): Amversio
betaine, Homocystinuria
Date of authorisation: 05/05/2022,,
, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Amvuttra
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): Anoro Ellipta (previously Anoro)
umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 08/05/2014,, Revision: 18, Authorised, Last updated: 22/11/2022
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Human medicine European public assessment report (EPAR): Apexxnar
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 8, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 10A, Pneumococcal polysaccharide serotype 11A, Pneumococcal polysaccharide serotype 12F, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 15b, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 22F, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 33F, Pneumococcal Infections
Date of authorisation: 14/02/2022,, Revision: 4, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Arikayce liposomal
Amikacin sulfate, Respiratory Tract Infections
Date of authorisation: 27/10/2020,, Revision: 1, Authorised, Last updated: 09/11/2021
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Human medicine European public assessment report (EPAR): Artesunate Amivas
artesunate, Malaria
Date of authorisation: 22/11/2021,,
, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Aspaveli
Pegcetacoplan, Hemoglobinuria, Paroxysmal
Date of authorisation: 13/12/2021,,
, Revision: 3, Authorised, Last updated: 06/09/2022
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Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,,
, Revision: 26, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Aybintio
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: 19/08/2020,,
, Revision: 6, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Ayvakyt (updated)
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,,
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, Revision: 6, Authorised, Last updated: 14/03/2023