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582 results

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public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter Withdrawn applications Remove Withdrawn applications filter Direct healthcare professional communication Remove Direct healthcare professional communication filter

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Human medicine European public assessment report (EPAR): Carvykti (updated)

ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022, , , , Revision: 1, Authorised, Last updated: 17/01/2023
List item

Human medicine European public assessment report (EPAR): Atriance (updated)

nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007, , , Revision: 26, Authorised, Last updated: 16/01/2023
List item

Human medicine European public assessment report (EPAR): Vyndaqel (updated)

tafamidis, Amyloidosis
Date of authorisation: 16/11/2011, , , , Revision: 23, Authorised, Last updated: 16/01/2023
List item

Human medicine European public assessment report (EPAR): Dimethyl fumarate Neuraxpharm (updated)

dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022, , Revision: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Koselugo (updated)

Selumetinib sulfate, Neurofibromatosis 1
Date of authorisation: 17/06/2021, , , , Revision: 4, Authorised, Last updated: 16/01/2023
List item

Human medicine European public assessment report (EPAR): Dimethyl fumarate Polpharma (updated)

dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022, , Revision: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord (updated)

cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020, , Revision: 3, Authorised, Last updated: 16/01/2023
List item

Human medicine European public assessment report (EPAR): Teriflunomide Mylan (updated)

Teriflunomide, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 09/11/2022, , Revision: 1, Authorised, Last updated: 16/01/2023
List item

Human medicine European public assessment report (EPAR): Idefirix (updated)

Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020, , , , Revision: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Hukyndra (updated)

adalimumab, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
Date of authorisation: 15/11/2021, , Revision: 3, Authorised, Last updated: 16/01/2023
List item

Human medicine European public assessment report (EPAR): Orphacol (updated)

cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012, , , , Revision: 12, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Sugammadex Amomed (updated)

sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 10/01/2023, , Authorised, Last updated: 13/01/2023
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Human medicine European public assessment report (EPAR): Pregabalin Mylan (updated)

pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 24/06/2015, , Revision: 16, Authorised, Last updated: 13/01/2023
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Human medicine European public assessment report (EPAR): Nivestim (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 07/06/2010, , Revision: 26, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Ebvallo (updated)

Tabelecleucel, Lymphoproliferative Disorders
Date of authorisation: 16/12/2022, , , , Authorised, Last updated: 12/01/2023
List item

Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)

aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015, , Revision: 15, Authorised, Last updated: 12/01/2023
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Human medicine European public assessment report (EPAR): Libmyris (updated)

adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Psoriasis; Hidradenitis Suppurativa; Crohn Disease; Colitis, Ulcerative; Uveitis
Date of authorisation: 12/11/2021, , Revision: 1, Authorised, Last updated: 11/01/2023
List item

Human medicine European public assessment report (EPAR): Natpar (updated)

parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017, , , , Revision: 13, Authorised, Last updated: 11/01/2023
List item

Human medicine European public assessment report (EPAR): Tacforius (updated)

tacrolimus monohydrate, Liver Transplantation; Kidney Transplantation
Date of authorisation: 08/12/2017, , Revision: 7, Authorised, Last updated: 10/01/2023
List item

Human medicine European public assessment report (EPAR): Nuvaxovid (updated)

SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021, , , Revision: 7, Authorised, Last updated: 10/01/2023
List item

Human medicine European public assessment report (EPAR): Deferasirox Mylan (updated)

deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 26/09/2019, , Revision: 8, Authorised, Last updated: 10/01/2023
List item

Human medicine European public assessment report (EPAR): Adakveo (updated)

Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020, , , , Revision: 3, Authorised, Last updated: 10/01/2023
List item

Human medicine European public assessment report (EPAR): Pregabalin Accord (updated)

pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 28/08/2015, , Revision: 15, Authorised, Last updated: 09/01/2023
List item

Human medicine European public assessment report (EPAR): Pemazyre (updated)

pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021, , , , Revision: 4, Authorised, Last updated: 09/01/2023
List item

Human medicine European public assessment report (EPAR): Benepali (updated)

etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis
Date of authorisation: 13/01/2016, , Revision: 18, Authorised, Last updated: 06/01/2023

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582 results

Human medicine European public assessment report (EPAR): Carvykti (updated)

Human medicine European public assessment report (EPAR): Atriance (updated)

Human medicine European public assessment report (EPAR): Vyndaqel (updated)

Human medicine European public assessment report (EPAR): Dimethyl fumarate Neuraxpharm (updated)

Human medicine European public assessment report (EPAR): Koselugo (updated)

Human medicine European public assessment report (EPAR): Dimethyl fumarate Polpharma (updated)

Human medicine European public assessment report (EPAR): Cabazitaxel Accord (updated)

Human medicine European public assessment report (EPAR): Teriflunomide Mylan (updated)

Human medicine European public assessment report (EPAR): Idefirix (updated)

Human medicine European public assessment report (EPAR): Hukyndra (updated)

Human medicine European public assessment report (EPAR): Orphacol (updated)

Human medicine European public assessment report (EPAR): Sugammadex Amomed (updated)

Human medicine European public assessment report (EPAR): Pregabalin Mylan (updated)

Human medicine European public assessment report (EPAR): Nivestim (updated)

Human medicine European public assessment report (EPAR): Ebvallo (updated)

Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)

Human medicine European public assessment report (EPAR): Libmyris (updated)

Human medicine European public assessment report (EPAR): Natpar (updated)

Human medicine European public assessment report (EPAR): Tacforius (updated)

Human medicine European public assessment report (EPAR): Nuvaxovid (updated)

Human medicine European public assessment report (EPAR): Deferasirox Mylan (updated)

Human medicine European public assessment report (EPAR): Adakveo (updated)

Human medicine European public assessment report (EPAR): Pregabalin Accord (updated)

Human medicine European public assessment report (EPAR): Pemazyre (updated)

Human medicine European public assessment report (EPAR): Benepali (updated)