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Medicine
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Human medicine European public assessment report (EPAR): Noxafil (updated)
posaconazole, Candidiasis, Mycoses, Coccidioidomycosis, Aspergillosis
Date of authorisation: 25/10/2005, Revision: 28, Authorised, Last updated: 26/02/2021 -
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Human medicine European public assessment report (EPAR): Nyxoid (updated)
Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 09/11/2017, Revision: 5, Authorised, Last updated: 26/02/2021 -
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Human medicine European public assessment report (EPAR): Lamivudine Teva (updated)
lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009,, Revision: 10, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Tivicay (updated)
dolutegravir, HIV Infections
Date of authorisation: 16/01/2014, Revision: 24, Authorised, Last updated: 26/02/2021 -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)
clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009,, Revision: 16, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Taltz (updated)
ixekizumab, Psoriasis
Date of authorisation: 25/04/2016,, Revision: 12, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Suboxone (updated)
buprenorphine, naloxone, Opioid-Related Disorders
Date of authorisation: 26/09/2006, Revision: 19, Authorised, Last updated: 26/02/2021 -
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Human medicine European public assessment report (EPAR): Elocta (updated)
efmoroctocog alfa, Hemophilia A
Date of authorisation: 18/11/2015, Revision: 11, Authorised, Last updated: 26/02/2021 -
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Human medicine European public assessment report (EPAR): Mekinist (updated)
trametinib, Melanoma
Date of authorisation: 30/06/2014, Revision: 20, Authorised, Last updated: 26/02/2021 -
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Human medicine European public assessment report (EPAR): Myfenax (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,, Revision: 23, Authorised, Last updated: 26/02/2021
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Human medicine European public assessment report (EPAR): Fareston (updated)
toremifene, Breast Neoplasms
Date of authorisation: 14/02/1996, Revision: 23, Authorised, Last updated: 26/02/2021 -
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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: 3, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Revolade (updated)
Eltrombopag, Purpura, Thrombocytopenic, Idiopathic
Date of authorisation: 11/03/2010, Revision: 26, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Telzir (updated)
fosamprenavir calcium, HIV Infections
Date of authorisation: 12/07/2004, Revision: 45, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Ervebo (updated)
recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola
Date of authorisation: 11/11/2019,, Revision: 4, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Neuraceq (updated)
florbetaben (18F), Radionuclide Imaging, Alzheimer Disease
Date of authorisation: 20/02/2014, Revision: 16, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Tesavel (updated)
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 10/01/2008, Revision: 24, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Dectova (updated)
Zanamivir, Influenza, Human
Date of authorisation: 26/04/2019,, Revision: 2, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Trizivir (updated)
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 36, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Entecavir Mylan (updated)
entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017,, Revision: 3, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Kivexa (updated)
abacavir, lamivudine, HIV Infections
Date of authorisation: 16/12/2004, Revision: 33, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)
6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012,, Revision: 11, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Truberzi (updated)
eluxadoline, Irritable Bowel Syndrome, Diarrhea
Date of authorisation: 19/09/2016,, Revision: 6, Withdrawn, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Janumet (updated)
sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/07/2008,
Date of refusal: 18/02/2009, Revision: 27, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Ristaben (updated)
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 15/03/2010, Revision: 23, Authorised, Last updated: 25/02/2021