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466 results
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,
, Revision: 10, Authorised, Last updated: 09/12/2021
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Human medicine European public assessment report (EPAR): Azacitidine betapharm (updated)
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 24/03/2020,, Revision: 3, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Marixino (previously Maruxa) (updated)
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 28/04/2013,, Revision: 8, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Imatinib Accord (updated)
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 30/06/2013,, Revision: 17, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Febuxostat Krka (updated)
febuxostat, Hyperuricemia; Gout
Date of authorisation: 28/03/2019,, Revision: 2, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Repaglinide Krka (updated)
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 03/11/2009,, Revision: 7, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Enyglid (updated)
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 13/10/2009,, Revision: 8, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Temozolomide Sun (updated)
temozolomide, Glioma; Glioblastoma
Date of authorisation: 13/07/2011,, Revision: 18, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Spinraza (updated)
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,
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, Revision: 12, Authorised, Last updated: 08/12/2021
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Veterinary medicine European public assessment report (EPAR): Increxxa (updated)
tulathromycin, Cattle; Pigs; Sheep
Date of authorisation: 16/09/2020,, Revision: 2, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Capecitabine Accord (updated)
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,
, , Revision: 15, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Verkazia (updated)
ciclosporin, Conjunctivitis; Keratitis
Date of authorisation: 06/07/2018,, , Revision: 5, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Hemlibra (updated)
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, , Revision: 9, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Abecma (updated)
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: 2, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Aripiprazole Accord (updated)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 13, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Pregabalin Accord (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 28/08/2015,, Revision: 10, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Inrebic (updated)
fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders; Primary Myelofibrosis
Date of authorisation: 08/02/2021,, , Revision: 3, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Ebilfumin (updated)
oseltamivir, Influenza, Human
Date of authorisation: 22/05/2014,, Revision: 14, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 13, Authorised, Last updated: 07/12/2021
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Human medicine European public assessment report (EPAR): Miglustat Gen.Orph (updated)
miglustat, Gaucher Disease
Date of authorisation: 09/11/2017,, Revision: 7, Authorised, Last updated: 07/12/2021
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Veterinary medicine European public assessment report (EPAR): Tulissin (updated)
tulathromycin, Cattle; Pigs; Sheep
Date of authorisation: 24/04/2020,, Revision: 3, Authorised, Last updated: 07/12/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 12, Authorised, Last updated: 07/12/2021
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Human medicine European public assessment report (EPAR): Dexmedetomidine Accord (updated)
dexmedetomidine, Premedication
Date of authorisation: 13/02/2020,, Revision: 2, Authorised, Last updated: 07/12/2021
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 8, Authorised, Last updated: 06/12/2021
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, , , Revision: 4, Authorised, Last updated: 06/12/2021