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Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter Summaries of opinion Remove Summaries of opinion 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: 6, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Abevmy (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: 21/04/2021, , , Revision: 6, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Abiraterone Accord

abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 26/04/2021, , Revision: 1, Authorised, Last updated: 25/09/2023
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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: 4, Authorised, Last updated: 11/09/2023
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Human medicine European public assessment report (EPAR): Abrysvo

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): Actelsar HCT

Telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013, , Revision: 17, Authorised, Last updated: 24/10/2023
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Veterinary medicine European public assessment report (EPAR): Acticam

meloxicam, Dogs; Cats
Date of authorisation: 09/12/2008, , Revision: 9, Withdrawn, Last updated: 24/03/2021
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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: 29/09/2023
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Human medicine European public assessment report (EPAR): Adcetris

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: 4, Authorised, Last updated: 30/10/2023
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Human medicine European public assessment report (EPAR): Adynovi

rurioctocog alfa pegol, Hemophilia A
Date of authorisation: 08/01/2018, , Revision: 10, Authorised, Last updated: 03/10/2023
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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 (updated)

fremanezumab, Migraine Disorders
Date of authorisation: 28/03/2019, , Revision: 10, Authorised, Last updated: 20/11/2023
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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: 11, Authorised, Last updated: 11/10/2023
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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): 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): Alsitek

Masitinib mesilate, Amyotrophic Lateral Sclerosis
Date of refusal: 26/07/2018, , Refused, Last updated: 31/07/2018
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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: 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): 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): Amglidia

glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018, , Revision: 7, Authorised, Last updated: 25/09/2023
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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: 11, Authorised, Last updated: 17/08/2023