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323 results
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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: 17, Authorised, Last updated: 03/12/2021
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Human medicine European public assessment report (EPAR): Aripiprazole Accord (updated)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 12, Authorised, Last updated: 03/12/2021
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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,
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, Revision: 17, Authorised, Last updated: 03/12/2021
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Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,
, Revision: 23, Authorised, Last updated: 02/12/2021
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Human medicine European public assessment report (EPAR): Iclusig (updated)
ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013,, , 
, Revision: 22, Authorised, Last updated: 02/12/2021
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Human medicine European public assessment report (EPAR): Cabometyx (updated)
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,, Revision: 13, Authorised, Last updated: 01/12/2021
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Human medicine European public assessment report (EPAR): Lenvima (updated)
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,, , Revision: 16, Authorised, Last updated: 01/12/2021
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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,, , Revision: 11, Authorised, Last updated: 01/12/2021
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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: 10, Authorised, Last updated: 30/11/2021
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Veterinary medicine European public assessment report (EPAR): Lydaxx (updated)
tulathromycin, Cattle; Pigs; Sheep
Date of authorisation: 18/05/2020,, Revision: 2, Authorised, Last updated: 30/11/2021
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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: 16, Authorised, Last updated: 30/11/2021
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Human medicine European public assessment report (EPAR): Matever (updated)
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 25, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Zyllt (updated)
clopidogrel (as hydrogen sulfate), Peripheral Vascular Diseases; Stroke; Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 28/09/2009,, Revision: 15, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Isentress (updated)
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,, Revision: 41, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Tigecycline Accord (updated)
Tigecycline, Soft Tissue Infections; Intraabdominal Infections; Bacterial Infections; Skin Diseases, Infectious
Date of authorisation: 17/04/2020,, Revision: 1, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Rivaroxaban Mylan (updated)
rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021,, Authorised, Last updated: 29/11/2021
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Human medicine European public assessment report (EPAR): Spikevax (previously 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: 16, Authorised, Last updated: 26/11/2021
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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: 15, Authorised, Last updated: 26/11/2021
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 4, Authorised, Last updated: 25/11/2021
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Human medicine European public assessment report (EPAR): Daptomycin Hospira (updated)
daptomycin, Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 22/03/2017,, Revision: 11, Authorised, Last updated: 25/11/2021
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Human medicine European public assessment report (EPAR): Onpattro (updated)
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,, , , Revision: 8, Authorised, Last updated: 25/11/2021
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Human medicine European public assessment report (EPAR): Pioglitazone Teva (updated)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012,, Revision: 12, Authorised, Last updated: 24/11/2021
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Human medicine European public assessment report (EPAR): Talmanco (previously Tadalafil Generics) (updated)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 09/01/2017,, Revision: 6, Authorised, Last updated: 24/11/2021
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Human medicine European public assessment report (EPAR): Voriconazole Accord (updated)
voriconazole, Aspergillosis; Candidiasis; Mycoses
Date of authorisation: 16/05/2013,, Revision: 13, Authorised, Last updated: 24/11/2021
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Human medicine European public assessment report (EPAR): Ivozall (updated)
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/11/2019,, Revision: 3, Authorised, Last updated: 24/11/2021