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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Paediatric investigation plans Remove Paediatric investigation plans filter

Medicine type Accelerated assessment Remove Accelerated assessment filter Exceptional circumstances Remove Exceptional circumstances filter Additional monitoring Remove Additional monitoring filter Biosimilar Remove Biosimilar filter

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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, , , , Revision: 6, Authorised, Last updated: 27/07/2023
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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): Abrysvo (updated)

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): 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: 21/08/2023
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Human medicine European public assessment report (EPAR): Accofil

filgrastim, Neutropenia
Date of authorisation: 17/09/2014, , Revision: 14, Authorised, Last updated: 24/07/2023
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Human medicine European public assessment report (EPAR): Adakveo

Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020, , , , Revision: 6, Withdrawn, Last updated: 21/08/2023
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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: 9, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Aimovig

erenumab, Migraine Disorders
Date of authorisation: 26/07/2018, , Revision: 11, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Ajovy

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

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): Alpheon

recombinant human interferon alfa-2a, Hepatitis C, Chronic
Date of refusal: 05/09/2006, , Refused, Last updated: 28/06/2006
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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 (updated)

brigatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 22/11/2018, , Revision: 9, Authorised, Last updated: 22/09/2023
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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: 6, Authorised, Last updated: 26/07/2023
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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): 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): 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): Artesunate Amivas

artesunate, Malaria
Date of authorisation: 22/11/2021, , , Revision: 2, Authorised, Last updated: 23/08/2023