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Human medicine European public assessment report (EPAR): Dasatinib Accord (updated)
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,
, Revision: 1, Withdrawn, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Dasatinib Accordpharma (updated)
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Withdrawn, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): HyQvia (updated)
Human normal immunoglobulin, Immunologic Deficiency Syndromes
Date of authorisation: 16/05/2013, Revision: 19, Authorised, Last updated: 30/03/2023 -
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Human medicine European public assessment report (EPAR): Jyseleca (updated)
filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020,
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, Revision: 8, Authorised, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Rinvoq (updated)
upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019,, , Revision: 13, Authorised, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Olumiant (updated)
baricitinib, Arthritis, Rheumatoid
Date of authorisation: 13/02/2017,, Revision: 10, Authorised, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Cibinqo (updated)
Abrocitinib, Dermatitis, Atopic
Date of authorisation: 09/12/2021,, , Revision: 3, Authorised, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Xeljanz (updated)
Tofacitinib, Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,
Date of refusal: 25/04/2013,, Revision: 26, Authorised, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Tepadina (updated)
thiotepa, Hematopoietic Stem Cell Transplantation
Date of authorisation: 15/03/2010, Revision: 19, Authorised, Last updated: 29/03/2023 -
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Human medicine European public assessment report (EPAR): Kineret (updated)
anakinra, Arthritis, Rheumatoid; COVID-19 virus infection
Date of authorisation: 08/03/2002, Revision: 33, Authorised, Last updated: 29/03/2023 -
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Human medicine European public assessment report (EPAR): Azacitidine Accord (updated)
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Imvanex (updated)
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013,, 
, Revision: 25, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Alecensa (updated)
alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017,, Revision: 14, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Sancuso (updated)
granisetron, Vomiting; Cancer
Date of authorisation: 20/04/2012, Revision: 14, Authorised, Last updated: 29/03/2023 -
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Human medicine European public assessment report (EPAR): Otezla (updated)
apremilast, Arthritis, Psoriatic; Psoriasis
Date of authorisation: 15/01/2015, Revision: 20, Authorised, Last updated: 29/03/2023 -
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Human medicine European public assessment report (EPAR): Puregon (updated)
follitropin beta, Infertility; Hypogonadism
Date of authorisation: 02/05/1996, Revision: 34, Authorised, Last updated: 29/03/2023 -
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Human medicine European public assessment report (EPAR): Tecovirimat SIGA (updated)
Tecovirimat, Poxviridae Infections; Cowpox; Monkeypox; Vaccinia; Smallpox
Date of authorisation: 06/01/2022,, Revision: 1, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Aldurazyme (updated)
laronidase, Mucopolysaccharidosis I
Date of authorisation: 09/06/2003, Revision: 23, Authorised, Last updated: 29/03/2023 -
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Human medicine European public assessment report (EPAR): Febuxostat Mylan (updated)
febuxostat, Hyperuricemia; Arthritis, Gouty; Gout
Date of authorisation: 15/06/2017,, Revision: 9, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Azopt (updated)
brinzolamide, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 09/03/2000, Revision: 28, Authorised, Last updated: 29/03/2023 -
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Human medicine European public assessment report (EPAR): Myozyme (updated)
alglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 28/03/2006, Revision: 23, Authorised, Last updated: 29/03/2023 -
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Human medicine European public assessment report (EPAR): Kesimpta (updated)
ofatumumab, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 26/03/2021,, Revision: 6, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Glivec (updated)
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Gastrointestinal Stromal Tumors; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 07/11/2001,, Revision: 45, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Sivextro (updated)
tedizolid phosphate, Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 23/03/2015, Revision: 21, Authorised, Last updated: 29/03/2023 -
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Human medicine European public assessment report (EPAR): Nyvepria (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,, 
, Revision: 5, Authorised, Last updated: 29/03/2023