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plans Remove Paediatric investigation plans filter Summaries of opinion Remove Summaries of opinion filter Withdrawn applications Remove Withdrawn applications filter

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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
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Human medicine European public assessment report (EPAR): Ocaliva

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , Revision: 15, Authorised, Last updated: 04/01/2023
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Human medicine European public assessment report (EPAR): Imvanex

modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013, , , Revision: 23, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Hepcludex

Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020, , , , Revision: 8, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Opsumit

Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013, , Revision: 21, Authorised, Last updated: 22/12/2022
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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): 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): 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