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1139 results
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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: 5, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Entecavir Accord (updated)
Entecavir, Hepatitis B, Chronic
Date of authorisation: 25/09/2017,, Revision: 5, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Vaborem (updated)
meropenem trihydrate, vaborbactam, Urinary Tract Infections; Bacteremia; Bacterial Infections; Respiratory Tract Infections; Pneumonia; Pneumonia, Ventilator-Associated
Date of authorisation: 20/11/2018,
, Revision: 6, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Regkirona (updated)
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 4, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Tigecycline Accord (updated)
Tigecycline, Soft Tissue Infections; Intraabdominal Infections; Bacterial Infections; Skin Diseases, Infectious
Date of authorisation: 17/04/2020,, Revision: 4, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Sarclisa (updated)
Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020,, Revision: 5, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Veklury (updated)
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,, 
, Revision: 11, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,, 
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, Revision: 11, Authorised, Last updated: 28/07/2022
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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: 26, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Amversio (updated)
betaine, Homocystinuria
Date of authorisation: 05/05/2022,, , Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Xevudy (updated)
Sotrovimab, COVID-19 virus infection
Date of authorisation: 17/12/2021,, Revision: 3, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Supemtek (updated)
Influenza A virus subtype H1N1 haemagglutinin, recombinant, Influenza A virus subtype H3N2 haemagglutinin, recombinant, Influenza B virus Victoria lineage haemagglutinin, recombinant, Influenza B virus Yamagata lineage haemagglutinin, recombinant, Influenza, Human
Date of authorisation: 16/11/2020,, Revision: 2, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Libtayo (updated)
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,, , Revision: 12, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Jcovden (previously 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: 22, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Ryeqo (updated)
relugolix, norethisterone acetate, estradiol hemihydrate, Leiomyoma
Date of authorisation: 16/07/2021,, Revision: 4, Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Pemetrexed Sandoz (updated)
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/09/2015,, Revision: 7, Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Xenpozyme (updated)
Olipudase alfa, Acid sphingomyelinase deficiency (ASMD) type A/B or type B
Date of authorisation: 24/06/2022,, , Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi (updated)
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/07/2016,, Revision: 13, Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Grepid (updated)
clopidogrel (as besilate), Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 27/07/2009,, Revision: 25, Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Wegovy (updated)
semaglutide, Obesity; Overweight
Date of authorisation: 06/01/2022,, Revision: 1, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Zirabev (updated)
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,, 
, Revision: 11, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Granpidam (updated)
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 14/11/2016,, Revision: 7, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Rybelsus (updated)
semaglutide, Diabetes Mellitus, Type 2
Date of authorisation: 03/04/2020,, Revision: 4, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Orgovyx (updated)
relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022,, Revision: 3, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Bavencio (updated)
avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017,, Revision: 13, Authorised, Last updated: 26/07/2022