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Medicine type Conditional approval Remove Conditional approval filter Biosimilar Remove Biosimilar filter Orphan medicine Remove Orphan medicine filter Accelerated assessment Remove Accelerated assessment filter Generic Remove Generic filter

Medicine Summaries of opinion Remove Summaries of opinion filter European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Referrals Remove Referrals 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): 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): 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): 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): 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): 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): 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): 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): 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
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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: 08/06/2023