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Human medicine European public assessment report (EPAR): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,,
, Revision: 23, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Revestive
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,,
, Revision: 19, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Xospata
gilteritinib fumarate, Leukemia, Myeloid, Acute
Date of authorisation: 24/10/2019,,
, Revision: 3, Authorised, Last updated: 20/05/2022
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Human medicine European public assessment report (EPAR): Kymriah
tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018,,
, Revision: 11, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Ayvakyt
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,,
, Revision: 4, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Cometriq
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, Revision: 24, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Tobi Podhaler
Tobramycin, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 20/07/2011,, Revision: 19, Authorised, Last updated: 13/05/2022
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Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,,
, Revision: 33, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): SomaKit TOC
edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016,, Revision: 11, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Galafold
migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,,
, Revision: 15, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Iclusig
ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013,,
, Revision: 23, Authorised, Last updated: 11/05/2022
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Human medicine European public assessment report (EPAR): Naglazyme
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006,,
, Revision: 19, Authorised, Last updated: 10/05/2022
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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: 30, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,,
, Revision: 6, Authorised, Last updated: 10/05/2022
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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: 13, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Poteligeo
Mogamulizumab, Sezary Syndrome; Mycosis Fungoides
Date of authorisation: 22/11/2018,,
, Revision: 5, Authorised, Last updated: 28/04/2022
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Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,,
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, Revision: 6, Authorised, Last updated: 28/04/2022
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Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009,, Revision: 7, Authorised, Last updated: 26/04/2022
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Human medicine European public assessment report (EPAR): Oxbryta
Voxelotor, Anemia; Anemia, Hemolytic; Anemia, Sickle Cell
Date of authorisation: 14/02/2022,,
, Revision: 1, Authorised, Last updated: 13/04/2022
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Human medicine European public assessment report (EPAR): Ngenla
somatrogon, Growth and Development
Date of authorisation: 14/02/2022,,
, Revision: 2, Authorised, Last updated: 13/04/2022
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Human medicine European public assessment report (EPAR): Imvanex
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine
Date of authorisation: 31/07/2013,,
, Revision: 20, Authorised, Last updated: 12/04/2022
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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,,
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, Revision: 4, Authorised, Last updated: 07/04/2022
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Human medicine European public assessment report (EPAR): Obizur
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,,
, Revision: 9, Authorised, Last updated: 07/04/2022
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Human medicine European public assessment report (EPAR): Foclivia
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 18/10/2009,, Revision: 12, Authorised, Last updated: 06/04/2022
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Human medicine European public assessment report (EPAR): Lamzede
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,,
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, Revision: 4, Authorised, Last updated: 05/04/2022