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Categories Veterinary Remove Veterinary filter Human Remove Human filter

Medicine type Orphan medicine Remove Orphan medicine filter Exceptional circumstances Remove Exceptional circumstances filter Accelerated assessment Remove Accelerated assessment filter

Medicine Orphan designations Remove Orphan designations filter European public assessment reports (EPAR) Remove European public assessment reports (EPAR) 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: 5, Authorised, Last updated: 21/12/2022
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Human medicine European public assessment report (EPAR): Yescarta

axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018, , , Revision: 10, Authorised, Last updated: 16/12/2022
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Human medicine European public assessment report (EPAR): Elaprase

idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007, , , Revision: 25, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Nyxthracis (previously Obiltoxaximab SFL)

nyxthracis, Anthrax
Date of authorisation: 18/11/2020, , , , Revision: 3, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Scemblix

asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022, , , Revision: 1, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Gazyvaro

Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014, , , Revision: 14, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Mylotarg

gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018, , , Revision: 11, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Livmarli

Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022, , , , Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)

dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017, , , , Revision: 12, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Namuscla

Mexiletine hydrochloride, Myotonic Disorders
Date of authorisation: 18/12/2018, , Revision: 4, Authorised, Last updated: 13/12/2022
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Human medicine European public assessment report (EPAR): Onivyde pegylated liposomal (previously known as Onivyde)

irinotecan anhydrous free-base, Pancreatic Neoplasms
Date of authorisation: 14/10/2016, , Revision: 11, Authorised, Last updated: 13/12/2022
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Human medicine European public assessment report (EPAR): Takhzyro

lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018, , , , Revision: 10, Authorised, Last updated: 13/12/2022
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Human medicine European public assessment report (EPAR): Xermelo

telotristat etiprate, Carcinoid Tumor; Neuroendocrine Tumors
Date of authorisation: 17/09/2017, , Revision: 15, Authorised, Last updated: 12/12/2022
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Human medicine European public assessment report (EPAR): Jorveza

budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018, , , Revision: 6, Authorised, Last updated: 06/12/2022
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Human medicine European public assessment report (EPAR): Zytiga

abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011, , Revision: 26, Authorised, Last updated: 06/12/2022
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Human medicine European public assessment report (EPAR): Nexavar

sorafenib, Carcinoma, Hepatocellular; Carcinoma, Renal Cell
Date of authorisation: 19/07/2006, , Revision: 32, Authorised, Last updated: 06/12/2022
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Human medicine European public assessment report (EPAR): Ngenla

somatrogon, Growth and Development
Date of authorisation: 14/02/2022, , , Revision: 4, Authorised, Last updated: 06/12/2022
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Human medicine European public assessment report (EPAR): Cabometyx

cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016, , Revision: 15, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Pyrukynd

mitapivat sulfate, Genetic Diseases, Inborn; Anemia, Hemolytic
Date of authorisation: 09/11/2022, , , Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Tecartus

Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020, , , , Revision: 3, Authorised, Last updated: 02/12/2022
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Human medicine European public assessment report (EPAR): Zynteglo

Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019, , , , , Revision: 5, Withdrawn, Last updated: 30/11/2022
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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: 17, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Tavneos

Avacopan, Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 11/01/2022, , , Revision: 1, Authorised, Last updated: 25/11/2022
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Human medicine European public assessment report (EPAR): Prevymis

Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018, , Revision: 13, Authorised, Last updated: 24/11/2022
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Human medicine European public assessment report (EPAR): Kinpeygo

budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022, , , , Revision: 2, Authorised, Last updated: 23/11/2022