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Human medicine European public assessment report (EPAR): Movymia (updated)
teriparatide, Osteoporosis
Date of authorisation: 11/01/2017,,
, Revision: 8, Authorised, Last updated: 22/04/2021
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Human medicine European public assessment report (EPAR): Isentress (updated)
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,, Revision: 38, Authorised, Last updated: 22/04/2021
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Human medicine European public assessment report (EPAR): Cinryze (updated)
C1 inhibitor (human), Angioedemas, Hereditary
Date of authorisation: 15/06/2011,, Revision: 20, Authorised, Last updated: 22/04/2021
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Human medicine European public assessment report (EPAR): Benepali (updated)
etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis
Date of authorisation: 13/01/2016,, Revision: 14, Authorised, Last updated: 22/04/2021
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Human medicine European public assessment report (EPAR): Synjardy (updated)
empagliflozin, metformin, Diabetes Mellitus, Type 2
Date of authorisation: 27/05/2015,, Revision: 18, Authorised, Last updated: 22/04/2021
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Human medicine European public assessment report (EPAR): CoAprovel (updated)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 14/10/1998, Revision: 42, Authorised, Last updated: 22/04/2021 -
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Human medicine European public assessment report (EPAR): Aprovel (updated)
irbesartan, Hypertension
Date of authorisation: 26/08/1997, Revision: 43, Authorised, Last updated: 22/04/2021 -
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Human medicine European public assessment report (EPAR): Tasigna (updated)
nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 19/11/2007, Revision: 39, Authorised, Last updated: 22/04/2021 -
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Human medicine European public assessment report (EPAR): Ribavirin Teva (updated)
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 31/03/2009,, Revision: 15, Authorised, Last updated: 22/04/2021
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Human medicine European public assessment report (EPAR): Giotrif (updated)
afatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 25/09/2013, Revision: 14, Authorised, Last updated: 21/04/2021 -
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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,,
, Revision: 1, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Piqray (updated)
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,, Revision: 3, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Cabometyx (updated)
cabozantinib (s)-malate, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016,,
, Revision: 10, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Reblozyl (updated)
Luspatercept, Anemia, Myelodysplastic Syndromes, beta-Thalassemia
Date of authorisation: 25/06/2020,,
, Revision: 1, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Opdivo (updated)
nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Transitional Cell, Urologic Neoplasms
Date of authorisation: 19/06/2015, Revision: 36, Authorised, Last updated: 21/04/2021 -
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Hawaii/70/2019 (H1N1)pdm09-like strain (A/Nebraska/14/2019, wild type); A/Hong Kong/45/2019 (H3N2)-like strain (A/Delaware/39/2019, wild type); B/Washington/02/2019-like strain (B/Darwin/7/2019, wild type); B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 7, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Samsca (updated)
Tolvaptan, Inappropriate ADH Syndrome
Date of authorisation: 02/08/2009, Revision: 14, Authorised, Last updated: 21/04/2021 -
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Human medicine European public assessment report (EPAR): Telzir (updated)
fosamprenavir calcium, HIV Infections
Date of authorisation: 12/07/2004, Revision: 46, Authorised, Last updated: 21/04/2021 -
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Human medicine European public assessment report (EPAR): Herceptin (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 28/08/2000, Revision: 39, Authorised, Last updated: 21/04/2021 -
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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: 20/04/2021
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Human medicine European public assessment report (EPAR): Tecfidera (updated)
dimethyl fumarate, Multiple Sclerosis
Date of authorisation: 30/01/2014, Revision: 21, Authorised, Last updated: 20/04/2021 -
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Human medicine European public assessment report (EPAR): Vfend (updated)
voriconazole, Candidiasis, Mycoses, Aspergillosis
Date of authorisation: 19/03/2002, Revision: 48, Authorised, Last updated: 20/04/2021 -
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Human medicine European public assessment report (EPAR): Zykadia (updated)
ceritinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2015,, Revision: 14, Authorised, Last updated: 20/04/2021
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Human medicine European public assessment report (EPAR): Exforge (updated)
valsartan, amlodipine (as amlodipine besilate), Hypertension
Date of authorisation: 16/01/2007, Revision: 27, Authorised, Last updated: 20/04/2021 -
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Human medicine European public assessment report (EPAR): Vipidia (updated)
alogliptin, Diabetes Mellitus, Type 2
Date of authorisation: 18/09/2013, Revision: 6, Authorised, Last updated: 20/04/2021