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Medicine
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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: 11, Authorised, Last updated: 21/04/2022
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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: 14, Authorised, Last updated: 21/04/2022
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Human medicine European public assessment report (EPAR): Maviret (updated)
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,,
, Revision: 15, Authorised, Last updated: 21/04/2022
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Human medicine European public assessment report (EPAR): Entecavir Mylan (updated)
entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017,, Revision: 4, Authorised, Last updated: 20/04/2022
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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: 12, Authorised, Last updated: 20/04/2022
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Human medicine European public assessment report (EPAR): Cinacalcet Mylan
cinacalcet hydrochloride, Hyperparathyroidism, Secondary; Hypercalcemia
Date of authorisation: 19/11/2015,, Revision: 13, Authorised, Last updated: 13/04/2022
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Human medicine European public assessment report (EPAR): Eptifibatide Accord
eptifibatide, Myocardial Infarction
Date of authorisation: 11/01/2016,, Revision: 5, Authorised, Last updated: 13/04/2022
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Human medicine European public assessment report (EPAR): Dexmedetomidine Accord
dexmedetomidine, Premedication
Date of authorisation: 13/02/2020,, Revision: 4, Authorised, Last updated: 12/04/2022
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Human medicine European public assessment report (EPAR): Ibandronic acid Accord
ibandronic acid, Wounds and Injuries; Breast Diseases; Neoplastic Processes; Calcium Metabolism Disorders; Water-Electrolyte Imbalance
Date of authorisation: 18/11/2012,, Revision: 13, Authorised, Last updated: 12/04/2022
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d.
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 28/04/2017,, Revision: 9, Authorised, Last updated: 12/04/2022
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Human medicine European public assessment report (EPAR): Vosevi
Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,,
, Revision: 11, Authorised, Last updated: 11/04/2022
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 2, Authorised, Last updated: 08/04/2022
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Human medicine European public assessment report (EPAR): Pregabalin Mylan
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 24/06/2015,, Revision: 12, Authorised, Last updated: 08/04/2022
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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: 15, Authorised, Last updated: 07/04/2022
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Human medicine European public assessment report (EPAR): Febuxostat Krka
febuxostat, Hyperuricemia; Gout
Date of authorisation: 28/03/2019,, Revision: 3, Authorised, Last updated: 07/04/2022
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Human medicine European public assessment report (EPAR): Daptomycin Hospira
daptomycin, Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 22/03/2017,, Revision: 13, Authorised, Last updated: 06/04/2022
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Human medicine European public assessment report (EPAR): Nimvastid
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/05/2009,, Revision: 9, Authorised, Last updated: 06/04/2022
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Human medicine European public assessment report (EPAR): Tigecycline Accord
Tigecycline, Soft Tissue Infections; Intraabdominal Infections; Bacterial Infections; Skin Diseases, Infectious
Date of authorisation: 17/04/2020,, Revision: 3, Authorised, Last updated: 04/04/2022
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Human medicine European public assessment report (EPAR): Oxervate
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,,
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, Revision: 1, Authorised, Last updated: 04/04/2022
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Human medicine European public assessment report (EPAR): Azacitidine Accord
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 4, Authorised, Last updated: 04/04/2022
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Human medicine European public assessment report (EPAR): Pemetrexed Krka
pemetrexed disodium, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/05/2018,, Revision: 4, Authorised, Last updated: 01/04/2022
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Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,,
, Revision: 18, Authorised, Last updated: 01/04/2022
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Human medicine European public assessment report (EPAR): Lenalidomide Accord
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 9, Authorised, Last updated: 31/03/2022
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Human medicine European public assessment report (EPAR): Azacitidine Mylan
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Revision: 3, Authorised, Last updated: 30/03/2022
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Human medicine European public assessment report (EPAR): Dasatinib Accord
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Authorised, Last updated: 30/03/2022