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Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva (updated)
lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011,, Revision: 12, Authorised, Last updated: 11/02/2021
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan (updated)
tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016,, Revision: 12, Authorised, Last updated: 11/02/2021
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Human medicine European public assessment report (EPAR): Levetiracetam Actavis Group (updated)
levetiracetam, Epilepsy
Date of authorisation: 04/12/2011,, Revision: 14, Authorised, Last updated: 10/02/2021
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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: 7, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Duloxetine Zentiva (updated)
duloxetine, Anxiety Disorders, Depressive Disorder, Major, Neuralgia, Diabetes Mellitus
Date of authorisation: 20/08/2015,, Revision: 8, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Levetiracetam Accord (updated)
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 12, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi (updated)
pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 22/07/2016,, Revision: 10, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,,
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, Revision: 1, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva (updated)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 26/11/2009,, Revision: 18, Authorised, Last updated: 05/02/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,,
, Authorised, Last updated: 05/02/2021
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Human medicine European public assessment report (EPAR): Desloratadine ratiopharm (updated)
desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal
Date of authorisation: 13/01/2012,, Revision: 9, Authorised, Last updated: 03/02/2021
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Human medicine European public assessment report (EPAR): Mycophenolate mofetil Teva (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,, Revision: 22, Authorised, Last updated: 03/02/2021
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Human medicine European public assessment report (EPAR): Raloxifene Teva (updated)
raloxifene hydrochloride, Osteoporosis, Postmenopausal
Date of authorisation: 29/04/2010,, Revision: 9, Authorised, Last updated: 03/02/2021
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Human medicine European public assessment report (EPAR): Levetiracetam Teva (updated)
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 16, Authorised, Last updated: 02/02/2021
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Human medicine European public assessment report (EPAR): Pregabalin Mylan Pharma (updated)
pregabalin, Anxiety Disorders, Neuralgia, Epilepsy
Date of authorisation: 25/06/2015,, Revision: 7, Authorised, Last updated: 02/02/2021
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Human medicine European public assessment report (EPAR): Amlodipine / Valsartan Mylan (updated)
Amlodipine besilate, valsartan, Hypertension
Date of authorisation: 22/03/2016,, Revision: 6, Authorised, Last updated: 02/02/2021
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka (updated)
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 09/12/2016,, Revision: 8, Authorised, Last updated: 02/02/2021
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Human medicine European public assessment report (EPAR): Bortezomib Accord (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,, Revision: 8, Authorised, Last updated: 02/02/2021
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Human medicine European public assessment report (EPAR): Prevymis (updated)
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,,
, Revision: 8, Authorised, Last updated: 01/02/2021
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Human medicine European public assessment report (EPAR): Rydapt (updated)
Midostaurin, Leukemia, Myeloid, Acute, Mastocytosis
Date of authorisation: 18/09/2017,,
, Revision: 4, Authorised, Last updated: 01/02/2021
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Human medicine European public assessment report (EPAR): Bosulif (updated)
bosutinib (as monohydrate), Leukemia, Myeloid
Date of authorisation: 27/03/2013,,
, Revision: 20, Authorised, Last updated: 29/01/2021
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Veterinary medicine European public assessment report (EPAR): Sevohale (previously known as Sevocalm) (updated)
sevoflurane, Dogs, Cats
Date of authorisation: 21/06/2016,, Revision: 4, Authorised, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Gazyvaro (updated)
Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014,,
, Revision: 11, Authorised, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Imatinib Teva (updated)
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic-Myeloproliferative Diseases, Hypereosinophilic Syndrome, Dermatofibrosarcoma
Date of authorisation: 07/01/2013,, Revision: 15, Authorised, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Entecavir Accord (updated)
Entecavir, Hepatitis B, Chronic
Date of authorisation: 25/09/2017,, Revision: 3, Authorised, Last updated: 29/01/2021