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1922 results
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Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan (updated)
sitagliptin hydrochloride monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022,
, Revision: 1, Authorised, Last updated: 21/06/2022
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Human medicine European public assessment report (EPAR): Opsumit (updated)
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,
, Revision: 20, Authorised, Last updated: 21/06/2022
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Human medicine European public assessment report (EPAR): Kanuma (updated)
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,
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, , Revision: 8, Authorised, Last updated: 21/06/2022
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Human medicine European public assessment report (EPAR): Adcetris (updated)
Brentuximab vedotin, Lymphoma, Non-Hodgkin; Hodgkin Disease
Date of authorisation: 25/10/2012,, , Revision: 33, Authorised, Last updated: 21/06/2022
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Human medicine European public assessment report (EPAR): Torisel (updated)
Temsirolimus, Carcinoma, Renal Cell; Lymphoma, Mantle-Cell
Date of authorisation: 19/11/2007, Revision: 33, Authorised, Last updated: 21/06/2022 -
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Human medicine European public assessment report (EPAR): Jardiance (updated)
empagliflozin, Diabetes Mellitus, Type 2
Date of authorisation: 22/05/2014, Revision: 25, Authorised, Last updated: 20/06/2022 -
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Human medicine European public assessment report (EPAR): Maviret (updated)
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, , Revision: 16, Authorised, Last updated: 20/06/2022
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Human medicine European public assessment report (EPAR): Ozurdex (updated)
dexamethasone, Macular Edema; Uveitis
Date of authorisation: 26/07/2010, Revision: 17, Authorised, Last updated: 17/06/2022 -
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Human medicine European public assessment report (EPAR): Carvykti (updated)
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , 
, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Polpharma (updated)
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 01, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Ondexxya (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, , Revision: 12, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Gefitinib Mylan (updated)
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018,, Revision: 5, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Kisplyx (updated)
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, Revision: 17, Authorised, Last updated: 17/06/2022
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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: 20, Authorised, Last updated: 17/06/2022
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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: 25, Authorised, Last updated: 17/06/2022
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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: 21, Authorised, Last updated: 17/06/2022
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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: 23, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Revision: 2, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Sprycel (updated)
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 20/11/2006, Revision: 41, Authorised, Last updated: 17/06/2022 -
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Human medicine European public assessment report (EPAR): Xtandi (updated)
enzalutamide, Prostatic Neoplasms
Date of authorisation: 21/06/2013,
Date of refusal: 26/04/2013, Revision: 21, Authorised, Last updated: 17/06/2022 -
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 14, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Vildagliptin / Metformin hydrochloride Accord (updated)
metformin hydrochloride, vildagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 24/03/2022,, , Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Zynrelef (updated)
bupivacaine, meloxicam, Pain, Postoperative
Date of authorisation: 24/09/2020, Revision: 1, Authorised, Last updated: 16/06/2022 -
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Human medicine European public assessment report (EPAR): Enbrel (updated)
etanercept, Spondylitis, Ankylosing; Arthritis, Juvenile Rheumatoid; Arthritis, Psoriatic; Psoriasis; Arthritis, Rheumatoid
Date of authorisation: 02/02/2000, Revision: 69, Authorised, Last updated: 16/06/2022 -
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Human medicine European public assessment report (EPAR): Repatha (updated)
Evolocumab, Dyslipidemias; Hypercholesterolemia
Date of authorisation: 17/07/2015, Revision: 21, Authorised, Last updated: 16/06/2022