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Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,
, Revision: 13, Authorised, Last updated: 07/12/2021
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Human medicine European public assessment report (EPAR): Miglustat Gen.Orph (updated)
miglustat, Gaucher Disease
Date of authorisation: 09/11/2017,
, Revision: 7, Authorised, Last updated: 07/12/2021
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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,
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, Revision: 15, Authorised, Last updated: 07/12/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 12, Authorised, Last updated: 07/12/2021
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Human medicine European public assessment report (EPAR): Dexmedetomidine Accord (updated)
dexmedetomidine, Premedication
Date of authorisation: 13/02/2020,, Revision: 2, Authorised, Last updated: 07/12/2021
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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: 8, Authorised, Last updated: 06/12/2021
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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: 4, Authorised, Last updated: 06/12/2021
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Human medicine European public assessment report (EPAR): Jorveza (updated)
budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,
, , Revision: 3, Authorised, Last updated: 06/12/2021
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Human medicine European public assessment report (EPAR): Cablivi (updated)
Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018,, , Revision: 5, Authorised, Last updated: 06/12/2021
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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: 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,, , 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): SomaKit TOC (updated)
edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016,, Revision: 10, 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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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