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Human medicine European public assessment report (EPAR): Topotecan Teva
topotecan, Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 21/09/2009,
, Revision: 8, Withdrawn, Last updated: 13/07/2018
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Human medicine European public assessment report (EPAR): Masipro
Masitinib mesilate, Mastocytosis
Date of refusal: 18/12/2017,
, Refused, Last updated: 04/04/2018
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Human medicine European public assessment report (EPAR): Clopidogrel Acino
clopidogrel, Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/07/2009,, Revision: 6, Withdrawn, Last updated: 04/01/2018
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Human medicine European public assessment report (EPAR): Glybera
alipogene tiparvovec, Hyperlipoproteinemia Type I
Date of authorisation: 25/10/2012,
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, Revision: 8, Withdrawn, Last updated: 30/10/2017
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Pharma (previously Clopidogrel HCS)
clopidogrel (as hydrochloride), Myocardial Infarction; Peripheral Vascular Diseases; Stroke
Date of authorisation: 21/09/2009,, Revision: 9, Withdrawn, Last updated: 24/10/2017
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Human medicine European public assessment report (EPAR): Sabervel
irbesartan, Hypertension
Date of authorisation: 13/04/2012,, Revision: 2, Withdrawn, Last updated: 29/06/2017
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Human medicine European public assessment report (EPAR): Capecitabine SUN
capecitabine, Stomach Neoplasms; Breast Neoplasms; Colonic Neoplasms; Colorectal Neoplasms
Date of authorisation: 21/06/2013,, Revision: 3, Withdrawn, Last updated: 22/12/2016
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva Generics
zoledronic acid monohydrate, Osteoporosis; Osteitis Deformans
Date of authorisation: 27/03/2014,, Revision: 2, Withdrawn, Last updated: 08/08/2016
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Human medicine European public assessment report (EPAR): Dropcys
mercaptamine, Corneal Diseases; Cystinosis
Date of refusal: 24/06/2016,, Refused, Last updated: 25/07/2016
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Human medicine European public assessment report (EPAR): Repso
leflunomide, Arthritis, Rheumatoid; Arthritis, Psoriatic
Date of authorisation: 14/03/2011,, Revision: 11, Withdrawn, Last updated: 21/04/2016
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Human medicine European public assessment report (EPAR): Heparesc
Human heterologous liver cells, Urea Cycle Disorders, Inborn
Date of refusal: 21/12/2015,, Refused, Last updated: 04/04/2016
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Human medicine European public assessment report (EPAR): Paglitaz
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2012,, Revision: 1, Withdrawn, Last updated: 10/03/2016
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Human medicine European public assessment report (EPAR): Lympreva
dasiprotimut-t, Lymphoma, Non-Hodgkin
Date of refusal: 03/07/2015,, Refused, Last updated: 17/07/2015
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Human medicine European public assessment report (EPAR): Clopidogrel DURA
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 21/07/2009,, Revision: 6, Withdrawn, Last updated: 10/07/2015
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Human medicine European public assessment report (EPAR): Pumarix
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) , Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 04/03/2011,, Revision: 4, Withdrawn, Last updated: 17/03/2015
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Human medicine European public assessment report (EPAR): Docetaxel Mylan
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 31/01/2012,, Revision: 6, Withdrawn, Last updated: 12/03/2015
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Pharma B.V.
clopidogrel (as hydrobromide), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 16/06/2011,, Revision: 4, Withdrawn, Last updated: 03/02/2015
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Human medicine European public assessment report (EPAR): Masiviera
masitinib, Pancreatic Neoplasms, Refused, Last updated: 06/01/2015
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Human medicine European public assessment report (EPAR): Topotecan Eagle
topotecan (as hydrochloride), Carcinoma; Small Cell Lung Carcinoma
Date of authorisation: 22/12/2011,, Revision: 2, Withdrawn, Last updated: 14/11/2014
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Human medicine European public assessment report (EPAR): Pioglitazone Krka
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2012,, Revision: 2, Withdrawn, Last updated: 26/09/2014
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Human medicine European public assessment report (EPAR): Rivastigmine 3M Health Care Ltd
rivastigmine, Alzheimer Disease
Date of authorisation: 03/04/2014,, Revision: 1, Withdrawn, Last updated: 18/09/2014
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Human medicine European public assessment report (EPAR): Clopidogrel Qualimed
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 23/09/2009,, Revision: 4, Withdrawn, Last updated: 08/09/2014
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Human medicine European public assessment report (EPAR): Olanzapine Cipla (previously Olanzapine Neopharma)
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 14/11/2007,, Revision: 12, Withdrawn, Last updated: 24/07/2014
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Generics B.V.
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/10/2010,, Revision: 3, Withdrawn, Last updated: 12/05/2014
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Human medicine European public assessment report (EPAR): Leflunomide Teva
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 10/03/2011,, Revision: 6, Withdrawn, Last updated: 18/03/2014