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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,,
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, Revision: 2, Authorised, Last updated: 19/04/2021
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Human medicine European public assessment report (EPAR): Tafinlar (updated)
dabrafenib mesilate, Melanoma
Date of authorisation: 26/08/2013, Revision: 24, Authorised, Last updated: 19/04/2021 -
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Human medicine European public assessment report (EPAR): Lonquex (updated)
lipegfilgrastim, Neutropenia
Date of authorisation: 25/07/2013, Revision: 20, Authorised, Last updated: 19/04/2021 -
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Human medicine European public assessment report (EPAR): Mekinist (updated)
trametinib, Melanoma
Date of authorisation: 30/06/2014, Revision: 21, Authorised, Last updated: 19/04/2021 -
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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: 39, Authorised, Last updated: 19/04/2021 -
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Human medicine European public assessment report (EPAR): Equidacent (updated)
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,,
, Revision: 2, Authorised, Last updated: 19/04/2021
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Human medicine European public assessment report (EPAR): Elebrato Ellipta (updated)
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 15/11/2017,, Revision: 8, Authorised, Last updated: 19/04/2021
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Human medicine European public assessment report (EPAR): MenQuadfi (updated)
Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 18/11/2020,, Revision: 1, Authorised, Last updated: 19/04/2021
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Human medicine European public assessment report (EPAR): Onglyza (updated)
Saxagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 30/09/2009, Revision: 19, Authorised, Last updated: 16/04/2021 -
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Human medicine European public assessment report (EPAR): Jinarc (updated)
Tolvaptan, Polycystic Kidney, Autosomal Dominant
Date of authorisation: 27/05/2015,, Revision: 15, Authorised, Last updated: 16/04/2021
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Human medicine European public assessment report (EPAR): DuoPlavin (updated)
clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome, Myocardial Infarction
Date of authorisation: 14/03/2010, Revision: 24, Authorised, Last updated: 16/04/2021 -
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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: 5, Authorised, Last updated: 16/04/2021
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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,,
, Authorised, Last updated: 16/04/2021
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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,,
, Revision: 5, Authorised, Last updated: 16/04/2021
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Human medicine European public assessment report (EPAR): Edistride (updated)
dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Date of authorisation: 09/11/2015, Revision: 16, Authorised, Last updated: 15/04/2021 -
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Human medicine European public assessment report (EPAR): Zometa (updated)
zoledronic acid, zoledronic acid monohydrate, Cancer, Fractures, Bone
Date of authorisation: 20/03/2001, Revision: 35, Authorised, Last updated: 15/04/2021 -
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Human medicine European public assessment report (EPAR): ellaOne (updated)
ulipristal, Contraception, Postcoital
Date of authorisation: 15/05/2009, Revision: 22, Authorised, Last updated: 15/04/2021 -
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Human medicine European public assessment report (EPAR): Jevtana (updated)
cabazitaxel, Prostatic Neoplasms
Date of authorisation: 17/03/2011, Revision: 19, Authorised, Last updated: 15/04/2021 -
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Human medicine European public assessment report (EPAR): Oncaspar (updated)
pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/01/2016,, Revision: 13, Authorised, Last updated: 15/04/2021
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Human medicine European public assessment report (EPAR): Yondelis (updated)
trabectedin, Ovarian Neoplasms, Sarcoma
Date of authorisation: 17/09/2007, Revision: 26, Authorised, Last updated: 14/04/2021 -
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Human medicine European public assessment report (EPAR): Instanyl (updated)
Fentanyl citrate, Pain, Cancer
Date of authorisation: 20/07/2009, Revision: 28, Authorised, Last updated: 14/04/2021 -
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Human medicine European public assessment report (EPAR): Zercepac (updated)
trastuzumab, Breast Neoplasms, Stomach Neoplasms
Date of authorisation: 27/07/2020,,
, Revision: 3, Authorised, Last updated: 14/04/2021
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Human medicine European public assessment report (EPAR): PecFent (updated)
fentanyl, Pain, Cancer
Date of authorisation: 31/08/2010, Revision: 20, Authorised, Last updated: 14/04/2021 -
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva (updated)
tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 15/09/2016,, Revision: 9, Authorised, Last updated: 14/04/2021
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Human medicine European public assessment report (EPAR): Fotivda (updated)
tivozanib, Carcinoma, Renal Cell
Date of authorisation: 24/08/2017,, Revision: 5, Authorised, Last updated: 14/04/2021