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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Direct healthcare professional communication Remove Direct healthcare professional communication filter

Medicine type Conditional approval Remove Conditional approval filter Exceptional circumstances Remove Exceptional circumstances filter Additional monitoring Remove Additional monitoring filter Generic Remove Generic filter Accelerated assessment Remove Accelerated assessment filter

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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: 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): Abiraterone Accord

abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 26/04/2021, , Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Abiraterone Krka

abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021, , Revision: 2, Authorised, Last updated: 08/03/2023
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Human medicine European public assessment report (EPAR): Abiraterone Mylan

abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021, , Revision: 2, Authorised, Last updated: 17/03/2023
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Human medicine European public assessment report (EPAR): Actelsar HCT (updated)

Telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013, , Revision: 15, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Adakveo

Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020, , , , 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 (updated)

rurioctocog alfa pegol, Hemophilia A
Date of authorisation: 08/01/2018, , Revision: 9, Authorised, Last updated: 01/06/2023
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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): Ambrisentan Mylan

ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019, , Revision: 4, Authorised, Last updated: 26/04/2023
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Human medicine European public assessment report (EPAR): Amifampridine SERB

amifampridine phosphate, Lambert-Eaton Myasthenic Syndrome; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Nervous System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Neuromuscular Diseases; Neuromuscular Junction Diseases; Immune System Diseases; Autoimmune Diseases; Autoimmune Diseases of the Nervous System; Cancer; Neoplasms
Date of authorisation: 19/05/2022, , Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Amlodipine / Valsartan Mylan

Amlodipine besilate, valsartan, Hypertension
Date of authorisation: 22/03/2016, , Revision: 10, Authorised, Last updated: 30/09/2022
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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): Anagrelide Mylan (updated)

Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018, , Revision: 8, Authorised, Last updated: 11/05/2023
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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