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113 results
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Human medicine European public assessment report (EPAR): Ivabradine JensonR
ivabradine hydrochloride, Angina Pectoris; Heart Failure
Date of authorisation: 11/11/2016,
, Withdrawn, Last updated: 20/12/2018
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva Pharma
zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Date of authorisation: 15/08/2012,, Revision: 11, Withdrawn, Last updated: 12/12/2018
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Human medicine European public assessment report (EPAR): Raplixa
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 19/03/2015,
, Revision: 6, Withdrawn, Last updated: 10/10/2018
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Human medicine European public assessment report (EPAR): Imatinib Teva B.V.
imatinib mesilate, Dermatofibrosarcoma; Gastrointestinal Stromal Tumors; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 15/11/2017,, Withdrawn, Last updated: 09/10/2018
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Human medicine European public assessment report (EPAR): Alsitek
Masitinib mesilate, Amyotrophic Lateral Sclerosis
Date of refusal: 26/07/2018,
, Refused, Last updated: 31/07/2018
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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Date of authorisation: 21/09/2009,, Revision: 8, Withdrawn, Last updated: 13/07/2018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): Zinbryta
daclizumab, Multiple Sclerosis
Date of authorisation: 01/07/2016,, Revision: 8, Withdrawn, Last updated: 28/06/2018
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Human medicine European public assessment report (EPAR): Olysio
simeprevir, Hepatitis C, Chronic
Date of authorisation: 14/05/2014,, Revision: 13, Withdrawn, Last updated: 23/05/2018
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Human medicine European public assessment report (EPAR): Vibativ
telavancin, Pneumonia, Bacterial; Cross Infection
Date of authorisation: 02/09/2011,, Revision: 10, Withdrawn, Last updated: 16/05/2018
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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): Evarrest
human fibrinogen, human thrombin, Hemostasis
Date of authorisation: 25/09/2013,, Revision: 4, Withdrawn, Last updated: 03/04/2018
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Human medicine European public assessment report (EPAR): Ristempa
pegfilgrastim, Neutropenia
Date of authorisation: 13/04/2015,, Revision: 3, Withdrawn, Last updated: 07/03/2018
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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,, 
, 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): Zontivity
vorapaxar sulfate, Myocardial Infarction
Date of authorisation: 19/01/2015,, Revision: 2, Withdrawn, Last updated: 20/09/2017
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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): Vitekta
elvitegravir, HIV Infections
Date of authorisation: 13/11/2013,, Revision: 4, Withdrawn, Last updated: 29/05/2017
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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): Incivo
telaprevir, Hepatitis C, Chronic
Date of authorisation: 19/09/2011,, Revision: 19, Withdrawn, Last updated: 06/10/2016
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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