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Human medicine European public assessment report (EPAR): Sildenafil Actavis (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009,
, Revision: 14, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Memantine Mylan (updated)
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013,, Revision: 7, Authorised, Last updated: 12/05/2021
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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,
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, Revision: 2, Authorised, Last updated: 12/05/2021
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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: 6, Authorised, Last updated: 12/05/2021
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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: 6, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 3, Authorised, Last updated: 12/05/2021
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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: 15, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Arsenic trioxide Accord (updated)
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 14/11/2019,, Revision: 3, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Deltyba (updated)
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, 
, , Revision: 16, Authorised, Last updated: 11/05/2021
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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: 6, Authorised, Last updated: 10/05/2021
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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,, , Revision: 2, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 6, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (updated)
efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017,, Revision: 10, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Bortezomib Hospira (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 11, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Translarna (updated)
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,, , , Revision: 19, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Ifirmasta (previously Irbesartan Krka) (updated)
irbesartan hydrochloride, Hypertension
Date of authorisation: 01/12/2008,, Revision: 13, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Ifirmacombi (updated)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 04/03/2011,, Revision: 12, Authorised, Last updated: 04/05/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 10, Authorised, Last updated: 30/04/2021
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Human medicine European public assessment report (EPAR): Nemdatine (updated)
memantine, Alzheimer Disease
Date of authorisation: 22/04/2013,
Date of refusal: 22/02/2013,, Revision: 10, Authorised, Last updated: 29/04/2021
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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: 8, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): Lorviqua (updated)
Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019,, , Revision: 5, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): Posaconazole Accord (updated)
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 2, Authorised, Last updated: 26/04/2021
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Human medicine European public assessment report (EPAR): Rivastigmine Actavis (updated)
rivastigmine hydrogen tartrate, Dementia, Alzheimer Disease, Parkinson Disease
Date of authorisation: 16/06/2011,, Revision: 14, Authorised, Last updated: 26/04/2021
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Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka) (updated)
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 20/04/2012,
, , Revision: 13, Authorised, Last updated: 23/04/2021
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Human medicine European public assessment report (EPAR): Natpar (updated)
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,, , , Revision: 9, Authorised, Last updated: 23/04/2021