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Medicine
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Human medicine European public assessment report (EPAR): Tyverb (updated)
lapatinib, Breast Neoplasms
Date of authorisation: 10/06/2008, Revision: 31, Authorised, Last updated: 15/01/2021 -
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Human medicine European public assessment report (EPAR): Toujeo (previously Optisulin) (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 26/06/2000, Revision: 31, Authorised, Last updated: 15/01/2021 -
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Human medicine European public assessment report (EPAR): Tresiba (updated)
insulin degludec, Diabetes Mellitus
Date of authorisation: 20/01/2013, Revision: 14, Authorised, Last updated: 15/01/2021 -
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Human medicine European public assessment report (EPAR): Brintellix (updated)
Vortioxetine, Depressive Disorder, Major
Date of authorisation: 18/12/2013, Revision: 16, Authorised, Last updated: 15/01/2021 -
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Human medicine European public assessment report (EPAR): Busulfan Fresenius Kabi (updated)
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 22/09/2014,, Revision: 8, Authorised, Last updated: 15/01/2021
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Human medicine European public assessment report (EPAR): INOmax (updated)
Nitric oxide, Hypertension, Pulmonary, Respiratory Insufficiency
Date of authorisation: 01/08/2001, Revision: 22, Authorised, Last updated: 15/01/2021 -
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Human medicine European public assessment report (EPAR): Grepid (updated)
clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 27/07/2009,, Revision: 21, Authorised, Last updated: 15/01/2021
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Human medicine European public assessment report (EPAR): Lenvima (updated)
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,,
, Revision: 14, Authorised, Last updated: 15/01/2021
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Human medicine European public assessment report (EPAR): Neulasta (updated)
pegfilgrastim, Neutropenia, Cancer
Date of authorisation: 22/08/2002, Revision: 35, Authorised, Last updated: 14/01/2021 -
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Human medicine European public assessment report (EPAR): Nexium Control (updated)
esomeprazole, Gastroesophageal Reflux
Date of authorisation: 26/08/2013, Revision: 14, Authorised, Last updated: 14/01/2021 -
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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: 12, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Zonisamide Mylan (updated)
zonisamide, Epilepsy
Date of authorisation: 31/03/2016,, Revision: 5, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Zonegran (updated)
zonisamide, Epilepsies, Partial
Date of authorisation: 10/03/2005, Revision: 32, Authorised, Last updated: 14/01/2021 -
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Human medicine European public assessment report (EPAR): Exelon (updated)
rivastigmine, Dementia, Alzheimer Disease, Parkinson Disease
Date of authorisation: 11/05/1998, Revision: 40, Authorised, Last updated: 14/01/2021 -
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Human medicine European public assessment report (EPAR): Lixiana (updated)
edoxaban tosylate, Stroke, Venous Thromboembolism
Date of authorisation: 19/06/2015, Revision: 13, Authorised, Last updated: 14/01/2021 -
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Human medicine European public assessment report (EPAR): Prometax (updated)
rivastigmine, Alzheimer Disease, Parkinson Disease, Dementia
Date of authorisation: 03/12/1998, Revision: 38, Authorised, Last updated: 14/01/2021 -
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Human medicine European public assessment report (EPAR): Rubraca (updated)
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,,
, Revision: 5, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Mayzent (updated)
Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/01/2020,, Revision: 4, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Holoclar (updated)
ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation, Corneal Diseases
Date of authorisation: 17/02/2015,,
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, Revision: 7, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Valdoxan (updated)
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009, Revision: 22, Authorised, Last updated: 14/01/2021 -
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Human medicine European public assessment report (EPAR): Thymanax (updated)
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009,
Date of refusal: 18/11/2006, Revision: 22, Authorised, Last updated: 14/01/2021 -
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Human medicine European public assessment report (EPAR): Clopidogrel Krka (updated)
clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 23/09/2009,, Revision: 15, Authorised, Last updated: 13/01/2021
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Human medicine European public assessment report (EPAR): Hexyon (updated)
diphtheria toxoid adsorbed on aluminium hydroxide, hydrated, filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 23, Authorised, Last updated: 13/01/2021 -
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Human medicine European public assessment report (EPAR): Foclivia (updated)
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 18/10/2009,, Revision: 10, Authorised, Last updated: 13/01/2021
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Human medicine European public assessment report (EPAR): Fycompa (updated)
perampanel, Epilepsies, Partial
Date of authorisation: 23/07/2012, Revision: 19, Authorised, Last updated: 13/01/2021