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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

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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): 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 (updated)

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 (updated)

Respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B, Respiratory Syncytial Virus Infections
Date of authorisation: 23/08/2023, , , Authorised, Last updated: 15/09/2023
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Human medicine European public assessment report (EPAR): Actelsar HCT

Telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013, , Revision: 15, Authorised, Last updated: 01/06/2023
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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: 21/08/2023
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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: 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): 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: 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: 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: 6, Authorised, Last updated: 05/07/2023
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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