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509 results

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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Paediatric investigation plans Remove Paediatric investigation plans filter

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Human medicine European public assessment report (EPAR): Vidaza (updated)

azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008, , Revision: 20, Authorised, Last updated: 16/02/2021
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Human medicine European public assessment report (EPAR): Udenyca (updated)

pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018, , , Revision: 3, Withdrawn, Last updated: 15/02/2021
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Human medicine European public assessment report (EPAR): Mysildecard (updated)

sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016, , Revision: 3, Authorised, Last updated: 15/02/2021
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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): Ritemvia (updated)

rituximab, Lymphoma, Non-Hodgkin, Microscopic Polyangiitis, Wegener Granulomatosis
Date of authorisation: 13/07/2017, , , Revision: 8, 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): Blitzima (updated)

rituximab, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017, , , Revision: 10, 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): Herzuma (updated)

trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 08/02/2018, , , Revision: 10, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Ontruzant (updated)

trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 15/11/2017, , , Revision: 8, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Insulin aspart Sanofi (updated)

insulin aspart, Diabetes Mellitus
Date of authorisation: 25/06/2020, , Revision: 1, 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, , , , Revision: 1, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): Zercepac (updated)

trastuzumab, Breast Neoplasms, Stomach Neoplasms
Date of authorisation: 27/07/2020, , , Revision: 2, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): Praxbind (updated)

idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015, , Revision: 9, Authorised, Last updated: 08/02/2021
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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): Omnitrope (updated)

somatropin, Turner Syndrome, Prader-Willi Syndrome, Dwarfism, Pituitary
Date of authorisation: 12/04/2006, , Revision: 16, 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
List item

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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509 results

Human medicine European public assessment report (EPAR): Vidaza (updated)

Human medicine European public assessment report (EPAR): Udenyca (updated)

Human medicine European public assessment report (EPAR): Mysildecard (updated)

Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva (updated)

Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan (updated)

Human medicine European public assessment report (EPAR): Ritemvia (updated)

Human medicine European public assessment report (EPAR): Levetiracetam Actavis Group (updated)

Human medicine European public assessment report (EPAR): Blitzima (updated)

Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH (updated)

Human medicine European public assessment report (EPAR): Duloxetine Zentiva (updated)

Human medicine European public assessment report (EPAR): Levetiracetam Accord (updated)

Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi (updated)

Human medicine European public assessment report (EPAR): Herzuma (updated)

Human medicine European public assessment report (EPAR): Ontruzant (updated)

Human medicine European public assessment report (EPAR): Insulin aspart Sanofi (updated)

Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)

Human medicine European public assessment report (EPAR): Zercepac (updated)

Human medicine European public assessment report (EPAR): Praxbind (updated)

Human medicine European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva (updated)

Human medicine European public assessment report (EPAR): Omnitrope (updated)

Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)

Human medicine European public assessment report (EPAR): Desloratadine ratiopharm (updated)

Human medicine European public assessment report (EPAR): Mycophenolate mofetil Teva (updated)

Human medicine European public assessment report (EPAR): Raloxifene Teva (updated)

Human medicine European public assessment report (EPAR): Levetiracetam Teva (updated)