18724 results
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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: 5, Authorised, Last updated: 22/07/2021
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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: 10, Authorised, Last updated: 22/07/2021
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Human medicine European public assessment report (EPAR): Epclusa (updated)
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,,
, Revision: 15, Authorised, Last updated: 22/07/2021
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Human medicine European public assessment report (EPAR): Armisarte (previously Pemetrexed Actavis) (updated)
pemetrexed diacid monohydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 18/01/2016, Revision: 9, Authorised, Last updated: 22/07/2021 -
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Human medicine European public assessment report (EPAR): Imcivree (updated)
Setmelanotide, Obesity
Date of authorisation: 16/07/2021,,
, Authorised, Last updated: 22/07/2021
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Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma) (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,,
, Revision: 5, Authorised, Last updated: 22/07/2021
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017,,
, Revision: 14, Authorised, Last updated: 22/07/2021
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Human medicine European public assessment report (EPAR): Accofil (updated)
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 12, Authorised, Last updated: 22/07/2021
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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: 10, Authorised, Last updated: 22/07/2021
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Human medicine European public assessment report (EPAR): Halaven (updated)
Eribulin, Breast Neoplasms, Liposarcoma
Date of authorisation: 17/03/2011, Revision: 23, Authorised, Last updated: 22/07/2021 -
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Human medicine European public assessment report (EPAR): Xalkori (updated)
crizotinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 23/10/2012, Revision: 29, Authorised, Last updated: 21/07/2021 -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva (updated)
emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016,, Revision: 6, Authorised, Last updated: 21/07/2021
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Human medicine European public assessment report (EPAR): Cosentyx (updated)
Secukinumab, Arthritis, Psoriatic, Psoriasis, Spondylitis, Ankylosing
Date of authorisation: 14/01/2015, Revision: 21, Authorised, Last updated: 21/07/2021 -
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Human medicine European public assessment report (EPAR): Xeloda (updated)
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 02/02/2001,, Revision: 27, Authorised, Last updated: 21/07/2021
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Human medicine European public assessment report (EPAR): Vizimpro (updated)
dacomitinib monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 02/04/2019,, Revision: 2, Authorised, Last updated: 21/07/2021
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Human medicine European public assessment report (EPAR): Epidyolex (updated)
Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic
Date of authorisation: 19/09/2019,, Revision: 8, Authorised, Last updated: 21/07/2021
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Human medicine European public assessment report (EPAR): Klisyri (updated)
tirbanibulin, Keratosis, Actinic
Date of authorisation: 16/07/2021,, Authorised, Last updated: 21/07/2021
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Human medicine European public assessment report (EPAR): Apixaban Accord (updated)
Apixaban, Venous Thromboembolism, Stroke, Arthroplasty
Date of authorisation: 23/07/2020,, Revision: 1, Authorised, Last updated: 21/07/2021
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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: 41, Authorised, Last updated: 21/07/2021 -
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Human medicine European public assessment report (EPAR): Ibrance (updated)
palbociclib, Breast Neoplasms
Date of authorisation: 09/11/2016,, Revision: 13, Authorised, Last updated: 21/07/2021
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Human medicine European public assessment report (EPAR): Yervoy (updated)
Ipilimumab, Melanoma
Date of authorisation: 13/07/2011, Revision: 40, Authorised, Last updated: 21/07/2021 -
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Human medicine European public assessment report (EPAR): Tracleer (updated)
bosentan (as monohydrate), Scleroderma, Systemic, Hypertension, Pulmonary
Date of authorisation: 14/05/2002, Revision: 40, Authorised, Last updated: 21/07/2021 -
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Human medicine European public assessment report (EPAR): Revolade (updated)
Eltrombopag, Purpura, Thrombocytopenic, Idiopathic
Date of authorisation: 11/03/2010, Revision: 27, Authorised, Last updated: 21/07/2021 -
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Human medicine European public assessment report (EPAR): Emgality (updated)
Galcanezumab, Migraine Disorders
Date of authorisation: 14/11/2018,, Revision: 6, Authorised, Last updated: 21/07/2021
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) 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: 06/01/2021,,
, Revision: 9, Authorised, Last updated: 21/07/2021