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570 results

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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Orphan designations Remove Orphan designations filter Summaries of opinion Remove Summaries of opinion filter Withdrawn applications Remove Withdrawn applications filter Paediatric investigation plans Remove Paediatric investigation plans filter

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

Raltegravir, HIV Infections
Date of authorisation: 19/12/2007, , Revision: 38, Authorised, Last updated: 22/04/2021
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Human medicine European public assessment report (EPAR): Ribavirin Teva (updated)

Ribavirin, Hepatitis C, Chronic
Date of authorisation: 31/03/2009, , Revision: 15, Authorised, Last updated: 22/04/2021
List item

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

adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021, , , Revision: 1, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Cabometyx (updated)

cabozantinib (s)-malate, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016, , , Revision: 10, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Comirnaty (updated)

Single-stranded, 5’-capped messenger RNA 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: 21/12/2020, , , Revision: 5, Authorised, Last updated: 20/04/2021
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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: 2, Authorised, Last updated: 19/04/2021
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)

ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021, , , Revision: 5, Authorised, Last updated: 16/04/2021
List item

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

tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 15/09/2016, , Revision: 9, Authorised, Last updated: 14/04/2021
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Human medicine European public assessment report (EPAR): Azacitidine Accord (updated)

azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020, , Revision: 1, Authorised, Last updated: 14/04/2021
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Human medicine European public assessment report (EPAR): Deferasirox Mylan (updated)

deferasirox, Iron Overload, beta-Thalassemia
Date of authorisation: 26/09/2019, , Revision: 4, Authorised, Last updated: 13/04/2021
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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: 9, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan (updated)

zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012, , Revision: 11, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Coagadex (updated)

Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016, , , , Revision: 7, Authorised, Last updated: 09/04/2021
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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: 3, Authorised, Last updated: 09/04/2021
List item

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

rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018, , , Revision: 6, Authorised, Last updated: 09/04/2021
List item

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

olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 12/12/2007, , Revision: 28, Authorised, Last updated: 08/04/2021
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Human medicine European public assessment report (EPAR): Brineura (updated)

cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017, , , , , Revision: 5, Authorised, Last updated: 08/04/2021
List item

Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (updated)

efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018, , Revision: 6, Authorised, Last updated: 08/04/2021
List item

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

Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019, , , Revision: 6, Authorised, Last updated: 07/04/2021
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Human medicine European public assessment report (EPAR): Kisplyx (updated)

lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016, , , Revision: 13, Authorised, Last updated: 07/04/2021
List item

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

pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 19/11/2015, , Revision: 11, Authorised, Last updated: 06/04/2021
List item

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

dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015, , , Revision: 19, Authorised, Last updated: 06/04/2021
List item

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

clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/11/2019, , Revision: 2, Authorised, Last updated: 31/03/2021
List item

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

levetiracetam, Epilepsy
Date of authorisation: 25/08/2011, , Revision: 17, Authorised, Last updated: 31/03/2021
List item

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

levetiracetam, Epilepsy
Date of authorisation: 03/10/2011, , Revision: 22, Authorised, Last updated: 31/03/2021

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570 results

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

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

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

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

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

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

Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)

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

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

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

Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka (updated)

Human medicine European public assessment report (EPAR): Zoledronic acid Mylan (updated)

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

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

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

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

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

Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (updated)

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

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

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

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

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

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

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