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Medicine
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Human medicine European public assessment report (EPAR): Orgovyx (updated)
relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022,
, Revision: 4, Authorised, Last updated: 17/08/2022
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Human medicine European public assessment report (EPAR): Prezista (updated)
darunavir, HIV Infections
Date of authorisation: 11/02/2007, Revision: 53, Authorised, Last updated: 17/08/2022 -
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Human medicine European public assessment report (EPAR): Duloxetine Zentiva (updated)
duloxetine, Neuralgia; Depressive Disorder, Major; Anxiety Disorders; Diabetes Mellitus
Date of authorisation: 20/08/2015,
, Revision: 11, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Zynquista (updated)
Sotagliflozin, Diabetes Mellitus, Type 1
Date of authorisation: 26/04/2019,, Revision: 3, Withdrawn, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Lokelma (updated)
sodium zirconium cyclosilicate, Hyperkalemia
Date of authorisation: 22/03/2018,, Revision: 6, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Brineura (updated)
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,, 
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, Revision: 6, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Relvar Ellipta (updated)
fluticasone furoate, vilanterol, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 13/11/2013, Revision: 22, Authorised, Last updated: 16/08/2022 -
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Human medicine European public assessment report (EPAR): HBVaxPro (updated)
hepatitis B, recombinant surface antigen, Hepatitis B; Immunization
Date of authorisation: 27/04/2001, Revision: 32, Authorised, Last updated: 16/08/2022 -
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Human medicine European public assessment report (EPAR): RotaTeq (updated)
rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1, Immunization; Rotavirus Infections
Date of authorisation: 26/06/2006, Revision: 34, Authorised, Last updated: 16/08/2022 -
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Human medicine European public assessment report (EPAR): Exviera (updated)
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, Revision: 25, Authorised, Last updated: 12/08/2022
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Human medicine European public assessment report (EPAR): Viekirax (updated)
Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015, Revision: 27, Authorised, Last updated: 12/08/2022 -
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Human medicine European public assessment report (EPAR): Sifrol (updated)
pramipexole dihydrochloride monohydrate, Restless Legs Syndrome; Parkinson Disease
Date of authorisation: 13/10/1997, Revision: 36, Authorised, Last updated: 12/08/2022 -
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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,
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, Revision: 23, Authorised, Last updated: 12/08/2022
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Human medicine European public assessment report (EPAR): Mirapexin (updated)
pramipexole dihydrochloride monohydrate, Restless Legs Syndrome; Parkinson Disease
Date of authorisation: 23/02/1998, Revision: 39, Authorised, Last updated: 12/08/2022 -
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Human medicine European public assessment report (EPAR): Veklury (updated)
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,, Revision: 12, Authorised, Last updated: 12/08/2022
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Human medicine European public assessment report (EPAR): Alecensa (updated)
alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017,, Revision: 12, Authorised, Last updated: 11/08/2022
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Human medicine European public assessment report (EPAR): Ranexa (previously Latixa) (updated)
ranolazine, Angina Pectoris
Date of authorisation: 08/07/2008, Revision: 22, Authorised, Last updated: 11/08/2022 -
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Human medicine European public assessment report (EPAR): Grasustek (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019,, 
, Revision: 3, Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Vaxelis (updated)
Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3, hepatitis B surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein., Meningitis, Haemophilus; Poliomyelitis; Tetanus; Diphtheria; Whooping Cough; Hepatitis B
Date of authorisation: 15/02/2016, Revision: 11, Authorised, Last updated: 10/08/2022 -
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Human medicine European public assessment report (EPAR): Metalyse (updated)
tenecteplase, Myocardial Infarction
Date of authorisation: 23/02/2001, Revision: 20, Authorised, Last updated: 10/08/2022 -
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Human medicine European public assessment report (EPAR): Gliolan (updated)
5-aminolevulinic acid hydrochloride, Glioma
Date of authorisation: 07/09/2007, Revision: 7, Authorised, Last updated: 10/08/2022 -
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, Revision: 33, Authorised, Last updated: 10/08/2022
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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: 27, Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Upstaza (updated)
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,, , , Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Adenuric (updated)
febuxostat, Gout
Date of authorisation: 21/04/2008, Revision: 22, Authorised, Last updated: 09/08/2022