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Medicine
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Human medicine European public assessment report (EPAR): Sycrest (updated)
asenapine (as maleate) , Bipolar Disorder
Date of authorisation: 01/09/2010, Revision: 18, Authorised, Last updated: 19/02/2021 -
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Human medicine European public assessment report (EPAR): Duavive (updated)
oestrogens conjugated, bazedoxifene, Postmenopause
Date of authorisation: 16/12/2014, Revision: 12, Authorised, Last updated: 19/02/2021 -
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Human medicine European public assessment report (EPAR): Recarbrio (updated)
imipenem monohydrate, cilastatin sodium, relebactam monohydrate, Gram-Negative Bacterial Infections
Date of authorisation: 13/02/2020,, Revision: 2, Authorised, Last updated: 19/02/2021
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Human medicine European public assessment report (EPAR): Nuceiva (updated)
Botulinum toxin type A, Skin Aging
Date of authorisation: 27/09/2019,, Revision: 2, Authorised, Last updated: 19/02/2021
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Human medicine European public assessment report (EPAR): Stocrin (updated)
efavirenz, HIV Infections
Date of authorisation: 28/05/1999, Revision: 45, Authorised, Last updated: 18/02/2021 -
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Human medicine European public assessment report (EPAR): Vimpat (updated)
lacosamide, Epilepsy
Date of authorisation: 29/08/2008, Revision: 34, Authorised, Last updated: 18/02/2021 -
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Human medicine European public assessment report (EPAR): Palonosetron Accord (updated)
Palonosetron, Vomiting, Nausea, Cancer
Date of authorisation: 26/05/2016,, Revision: 4, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): Adrovance (updated)
colecalciferol, alendronic acid (as sodium trihydrate), Osteoporosis, Postmenopausal
Date of authorisation: 04/01/2007, Revision: 22, Authorised, Last updated: 18/02/2021 -
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Human medicine European public assessment report (EPAR): Zavicefta (updated)
avibactam sodium, ceftazidime pentahydrate, Pneumonia, Bacterial, Soft Tissue Infections, Pneumonia, Urinary Tract Infections, Gram-Negative Bacterial Infections
Date of authorisation: 23/06/2016,, Revision: 11, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): Crysvita (updated)
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,,
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, Revision: 7, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Apotex) (updated)
clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 20, Authorised, Last updated: 17/02/2021
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Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 5, Authorised, Last updated: 17/02/2021
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Human medicine European public assessment report (EPAR): Enzepi (updated)
pancreas powder, Exocrine Pancreatic Insufficiency
Date of authorisation: 29/06/2016,, Revision: 1, Withdrawn, Last updated: 17/02/2021
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Human medicine European public assessment report (EPAR): EndolucinBeta (updated)
lutetium (177Lu) chloride, Radionuclide Imaging
Date of authorisation: 06/07/2016, Revision: 8, Authorised, Last updated: 16/02/2021 -
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Human medicine European public assessment report (EPAR): Piqray (updated)
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,, Revision: 2, Authorised, Last updated: 16/02/2021
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Human medicine European public assessment report (EPAR): Darunavir Mylan (updated)
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 8, Authorised, Last updated: 16/02/2021
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Human medicine European public assessment report (EPAR): Javlor (updated)
vinflunine, Carcinoma, Transitional Cell, Urologic Neoplasms
Date of authorisation: 21/09/2009, Revision: 9, Authorised, Last updated: 16/02/2021 -
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Human medicine European public assessment report (EPAR): Dafiro (updated)
amlodipine, valsartan, Hypertension
Date of authorisation: 15/01/2007, Revision: 27, Authorised, Last updated: 16/02/2021 -
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Human medicine European public assessment report (EPAR): Sprycel (updated)
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 20/11/2006, Revision: 35, Authorised, Last updated: 16/02/2021 -
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Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 20, Authorised, Last updated: 16/02/2021
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Human medicine European public assessment report (EPAR): Udenyca (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,,
, Revision: 3, Withdrawn, Last updated: 15/02/2021
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Human medicine European public assessment report (EPAR): Ultomiris (updated)
ravulizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 02/07/2019,, Revision: 4, Authorised, Last updated: 15/02/2021
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Human medicine European public assessment report (EPAR): Mysildecard (updated)
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016,, Revision: 3, Authorised, Last updated: 15/02/2021
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Human medicine European public assessment report (EPAR): Halaven (updated)
Eribulin, Breast Neoplasms, Liposarcoma
Date of authorisation: 17/03/2011, Revision: 22, Authorised, Last updated: 15/02/2021 -
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Human medicine European public assessment report (EPAR): Plavix (updated)
clopidogrel hydrogen sulfate, Stroke, Peripheral Vascular Diseases, Atrial Fibrillation, Myocardial Infarction, Acute Coronary Syndrome
Date of authorisation: 15/07/1998, Revision: 43, Authorised, Last updated: 12/02/2021