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762 results

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(EPAR) filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Withdrawn applications Remove Withdrawn applications filter

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

brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020, , Revision: 8, Authorised, Last updated: 26/05/2023
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Human medicine European public assessment report (EPAR): Breyanzi (updated)

CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
Date of authorisation: 04/04/2022, , Revision: 1, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Livmarli (updated)

Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022, , , , Revision: 1, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Galafold (updated)

Migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016, , , Revision: 16, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Evoltra (updated)

clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006, , , Revision: 33, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Nexviadyme (updated)

Avalglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 24/06/2022, , Revision: 2, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Kisplyx (updated)

lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016, , Revision: 19, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Alofisel (updated)

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): Tevagrastim (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008, , Revision: 17, Authorised, Last updated: 24/05/2023
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Human medicine European public assessment report (EPAR): Semglee (updated)

insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018, , , Revision: 8, Authorised, Last updated: 23/05/2023
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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: 27, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle) (updated)

insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021, , , Revision: 2, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)

A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018, , Revision: 13, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Heplisav B (updated)

hepatitis B surface antigen, Hepatitis B
Date of authorisation: 18/02/2021, , Revision: 3, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Benlysta (updated)

belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011, , Revision: 30, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Ajovy (updated)

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): Fluad Tetra (updated)

A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 IVR‐215) A/Darwin/9/2021 (H3N2) like strain (A/Darwin/6/2021 IVR-227) B/Austria/1359417/2021 like strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human
Date of authorisation: 20/05/2020, , Revision: 6, Authorised, Last updated: 22/05/2023
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Human medicine European public assessment report (EPAR): Eladynos (updated)

abaloparatide, Osteoporosis, Postmenopausal; Osteoporosis ,
Revision: 1, Authorised, Last updated: 22/05/2023
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Human medicine European public assessment report (EPAR): Ibrance (updated)

Palbociclib, Breast Neoplasms
Date of authorisation: 09/11/2016, , Revision: 15, Authorised, Last updated: 22/05/2023
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Human medicine European public assessment report (EPAR): Kanuma (updated)

sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015, , , , Revision: 9, Authorised, Last updated: 17/05/2023
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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: 13, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Hemlibra (updated)

Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018, , Revision: 15, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Remsima (updated)

infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013, , Revision: 34, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Libtayo (updated)

Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019, , Revision: 14, Authorised, Last updated: 17/05/2023
List item

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

Cipaglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 20/03/2023, , , Authorised, Last updated: 16/05/2023

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762 results

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

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

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

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

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

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

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

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

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

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

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

Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle) (updated)

Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)

Human medicine European public assessment report (EPAR): Heplisav B (updated)

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

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

Human medicine European public assessment report (EPAR): Fluad Tetra (updated)

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

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

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

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

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

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

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

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