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992 results

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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Referrals Remove Referrals filter Withdrawn applications Remove Withdrawn applications filter Paediatric investigation plans Remove Paediatric investigation plans filter Summaries of opinion Remove Summaries of opinion filter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): Fingolimod Accord

fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 25/06/2020, , Revision: 4, Authorised, Last updated: 18/08/2023
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Human medicine European public assessment report (EPAR): Nemdatine

memantine, Alzheimer Disease
Date of authorisation: 22/04/2013,
Date of refusal: 22/02/2013, , Revision: 13, Authorised, Last updated: 17/08/2023
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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): Lacosamide Accord

lacosamide, Epilepsy
Date of authorisation: 18/09/2017, , Revision: 12, Authorised, Last updated: 16/08/2023
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Human medicine European public assessment report (EPAR): Caprelsa

Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012, , Revision: 52, Authorised, Last updated: 16/08/2023
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Human medicine European public assessment report (EPAR): Takhzyro

lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018, , , Revision: 11, Authorised, Last updated: 16/08/2023
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Human medicine European public assessment report (EPAR): Deltyba

Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013, , , , Revision: 25, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Epclusa

Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016, , Revision: 21, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Tolvaptan Accord

Tolvaptan, Inappropriate ADH Syndrome ,
Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Tagrisso

osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016, , Revision: 18, Authorised, Last updated: 11/08/2023
List item

Human medicine European public assessment report (EPAR): Vpriv

velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010, , Revision: 20, Authorised, Last updated: 08/08/2023
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Human medicine European public assessment report (EPAR): Plerixafor Accord

Plerixafor, Multiple Myeloma; Hematopoietic Stem Cell Transplantation
Date of authorisation: 16/12/2022, , , Revision: 1, Authorised, Last updated: 07/08/2023
List item

Human medicine European public assessment report (EPAR): Arikayce liposomal

Amikacin sulfate, Respiratory Tract Infections
Date of authorisation: 27/10/2020, , Revision: 2, Authorised, Last updated: 04/08/2023
List item

Human medicine European public assessment report (EPAR): Capecitabine Accord

capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012, , Revision: 16, Authorised, Last updated: 03/08/2023
List item

Human medicine European public assessment report (EPAR): Idefirix

Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020, , , , Revision: 4, Authorised, Last updated: 01/08/2023
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Human medicine European public assessment report (EPAR): Ofev

nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015, , Revision: 24, Authorised, Last updated: 01/08/2023
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Human medicine European public assessment report (EPAR): Sogroya

Somapacitan, Growth
Date of authorisation: 31/03/2021, , , Revision: 2, Authorised, Last updated: 31/07/2023
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Human medicine European public assessment report (EPAR): Ztalmy

Ganaxolone, Epileptic Syndromes; Spasms, Infantile
Date of authorisation: 26/07/2023, , , Authorised, Last updated: 31/07/2023
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Human medicine European public assessment report (EPAR): Oprymea

pramipexole dihydrochloride monohydrate, Parkinson Disease
Date of authorisation: 12/09/2008, , Revision: 22, Authorised, Last updated: 31/07/2023
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Human medicine European public assessment report (EPAR): Luxturna

voretigene neparvovec, Leber Congenital Amaurosis; Retinitis Pigmentosa
Date of authorisation: 22/11/2018, , , Revision: 7, Authorised, Last updated: 28/07/2023
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord

cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020, , Revision: 5, Authorised, Last updated: 27/07/2023
List item

Human medicine European public assessment report (EPAR): Gefitinib Mylan

gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018, , Revision: 6, Authorised, Last updated: 27/07/2023
List item

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
List item

Human medicine European public assessment report (EPAR): Tecvayli

Teclistamab, Multiple Myeloma
Date of authorisation: 23/08/2022, , , Revision: 1, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Revestive

teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012, , , Revision: 22, Authorised, Last updated: 27/07/2023

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992 results

Human medicine European public assessment report (EPAR): Fingolimod Accord

Human medicine European public assessment report (EPAR): Nemdatine

Human medicine European public assessment report (EPAR): Amlodipine / Valsartan Mylan

Human medicine European public assessment report (EPAR): Lacosamide Accord

Human medicine European public assessment report (EPAR): Caprelsa

Human medicine European public assessment report (EPAR): Takhzyro

Human medicine European public assessment report (EPAR): Deltyba

Human medicine European public assessment report (EPAR): Epclusa

Human medicine European public assessment report (EPAR): Tolvaptan Accord

Human medicine European public assessment report (EPAR): Tagrisso

Human medicine European public assessment report (EPAR): Vpriv

Human medicine European public assessment report (EPAR): Plerixafor Accord

Human medicine European public assessment report (EPAR): Arikayce liposomal

Human medicine European public assessment report (EPAR): Capecitabine Accord

Human medicine European public assessment report (EPAR): Idefirix

Human medicine European public assessment report (EPAR): Ofev

Human medicine European public assessment report (EPAR): Sogroya

Human medicine European public assessment report (EPAR): Ztalmy

Human medicine European public assessment report (EPAR): Oprymea

Human medicine European public assessment report (EPAR): Luxturna

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

Human medicine European public assessment report (EPAR): Gefitinib Mylan

Human medicine European public assessment report (EPAR): Abecma

Human medicine European public assessment report (EPAR): Tecvayli

Human medicine European public assessment report (EPAR): Revestive