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Human medicine European public assessment report (EPAR): Abasaglar (previously Abasria)
insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014,, Revision: 12, Authorised, Last updated: 24/09/2021
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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): Abseamed
epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer
Date of authorisation: 27/08/2007,
Date of refusal: 18/06/2009,, Revision: 22, Authorised, Last updated: 14/10/2021
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Human medicine European public assessment report (EPAR): Accofil
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 13, Authorised, Last updated: 16/02/2023
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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: 4, Authorised, Last updated: 17/04/2023
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Human medicine European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 10/10/2009,, Revision: 11, Authorised, Last updated: 08/06/2022
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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
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 (updated)
fremanezumab, Migraine Disorders
Date of authorisation: 28/03/2019,, Revision: 9, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Alecensa
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 (updated)
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,,
, Revision: 10, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Alpivab
Peramivir, Influenza, Human
Date of authorisation: 13/04/2018,, Revision: 2, Withdrawn, Last updated: 09/12/2020
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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: 5, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Amgevita
adalimumab, Arthritis, Psoriatic; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,, Revision: 11, Authorised, Last updated: 18/01/2023
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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): Arepanrix
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 23/03/2010,, Revision: 1, Withdrawn, Last updated: 25/10/2011
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Human medicine European public assessment report (EPAR): Artesunate Amivas
artesunate, Malaria
Date of authorisation: 22/11/2021,,
, Revision: 1, Authorised, Last updated: 24/04/2023
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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