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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): Pregabalin Sandoz (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 9, 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): 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): 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): 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): 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): Lamivudine Teva Pharma B.V. (updated)
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,, Revision: 17, Authorised, Last updated: 03/12/2021
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan (updated)
emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 16/12/2016,, Revision: 10, Authorised, Last updated: 30/11/2021
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Veterinary medicine European public assessment report (EPAR): Lydaxx (updated)
tulathromycin, Cattle; Pigs; Sheep
Date of authorisation: 18/05/2020,, Revision: 2, Authorised, Last updated: 30/11/2021
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Human medicine European public assessment report (EPAR): Matever (updated)
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 25, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Zyllt (updated)
clopidogrel (as hydrogen sulfate), Peripheral Vascular Diseases; Stroke; Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 28/09/2009,, Revision: 15, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Tigecycline Accord (updated)
Tigecycline, Soft Tissue Infections; Intraabdominal Infections; Bacterial Infections; Skin Diseases, Infectious
Date of authorisation: 17/04/2020,, Revision: 1, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Rivaroxaban Mylan (updated)
rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021,, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Pemetrexed Lilly (updated)
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 14/09/2015,, Revision: 7, Withdrawn, Last updated: 26/11/2021
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Human medicine European public assessment report (EPAR): Daptomycin Hospira (updated)
daptomycin, Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 22/03/2017,, Revision: 11, Authorised, Last updated: 25/11/2021
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Human medicine European public assessment report (EPAR): Pioglitazone Teva (updated)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012,, Revision: 12, Authorised, Last updated: 24/11/2021