104 results
Keyword Fluvastatin Remove keyword
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Referral: Lescol
fluvastatin, associated names: Canef, Cardiol, Cardiol XL, Cranoc, Digardil, Digaril Prolib, Fluvastatin Novartis, Fluvastatina, Fractal, Leposit Prolib, Lescol Depot, Lescol Exel, Lescol LP, Lescol MR, Lescol Prolib, Lescol XL, Lipaxan, Lipaxin, Liposit, Locol, Lymetel, Primesin, Vaditon, Vaditon Prolib, Article 30 referrals
Status: European Commission final decision, opinion/position date: 19/11/2009, EC decision date: 15/03/2010, Last updated: 13/09/2011contains the active substance fluvastatin. Fluvastatin belongs to a group of medicines … Digardil, Digaril Prolib, Fluvastatin Novartis Fluvastatina, Fractal, Leposit Prolib … containing 20 mg or 40 mg fluvastatin Prolonged-release tablets … -
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National expert: Nikica Mirošević Skvrce, Agency for Medicinal Products and Medical Devices of Croatia (updated)
- Declaration of interests - 79.83 KB | PDF
- Curriculum Vitae - 17.52 KB | PDF
transplant patients taking fluvastatin: a case-control study. Pharmacogenomics … -
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National expert: Maria Paile Hyvarinen, Finnish Medicines Agency (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 21.3 KB | PDF
Enantiospecific Pharmacogenomics of Fluvastatin. Clin.Pharmacol.Ther., 2019 10 … -
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National expert: Donald Singer, European Medicines Agency (updated)
- Declaration of interests - 80.42 KB | PDF
- Curriculum Vitae - 26.71 KB | PDF
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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): Lopinavir/Ritonavir Mylan (updated)
lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016,
, Revision: 14, Authorised, Last updated: 09/06/2022
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Human medicine European public assessment report (EPAR): Nilemdo
Bempedoic acid, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 01/04/2020,
, Revision: 6, Authorised, Last updated: 08/04/2022
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Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, 
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, Revision: 6, Authorised, Last updated: 28/04/2022
e.g. estrone- 3-sulfate, fluvastatin, atorvastatin, pitavastatin … -
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Human medicine European public assessment report (EPAR): Nustendi
Bempedoic acid, Ezetimibe, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 27/03/2020,, Revision: 5, Authorised, Last updated: 21/04/2022
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Human medicine European public assessment report (EPAR): Nubeqa
darolutamide, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 27/03/2020,, Revision: 3, Authorised, Last updated: 20/04/2022
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Human medicine European public assessment report (EPAR): Ritonavir Mylan
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 12, Authorised, Last updated: 06/05/2022
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Human medicine European public assessment report (EPAR): Symtuza (updated)
darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/09/2017, Revision: 13, Authorised, Last updated: 09/06/2022 -
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Human medicine European public assessment report (EPAR): Rukobia
fostemsavir trometamol, HIV Infections
Date of authorisation: 04/02/2021,, Revision: 2, Authorised, Last updated: 11/04/2022
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Human medicine European public assessment report (EPAR): Prevymis
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, , Revision: 10, Authorised, Last updated: 10/01/2022
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Human medicine European public assessment report (EPAR): Paxlovid
(1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido) butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide [PF-07321332], ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022,, Revision: 1, Authorised, Last updated: 29/04/2022
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Human medicine European public assessment report (EPAR): Evotaz
cobicistat, atazanavir, HIV Infections
Date of authorisation: 13/07/2015, Revision: 12, Authorised, Last updated: 18/02/2022 -
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Human medicine European public assessment report (EPAR): NexoBrid
proteolytic enzymes enriched in bromelain, Debridement
Date of authorisation: 18/12/2012,, , Revision: 12, Authorised, Last updated: 21/12/2021
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Human medicine European public assessment report (EPAR): Zepatier
elbasvir, grazoprevir, Hepatitis C, Chronic
Date of authorisation: 22/07/2016, Revision: 11, Authorised, Last updated: 09/02/2022 -
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Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, Revision: 23, Authorised, Last updated: 14/12/2021
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Human medicine European public assessment report (EPAR): Vosevi
Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, Revision: 12, Authorised, Last updated: 02/06/2022
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Human medicine European public assessment report (EPAR): Reyataz
atazanavir (as sulfate), HIV Infections
Date of authorisation: 01/03/2004, Revision: 52, Authorised, Last updated: 18/02/2022 -
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Human medicine European public assessment report (EPAR): Atazanavir Mylan
atazanavir (as sulfate), HIV Infections
Date of authorisation: 22/08/2016,, Revision: 11, Authorised, Last updated: 03/02/2022
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Human medicine European public assessment report (EPAR): Atazanavir Krka
atazanavir (as sulfate), HIV Infections
Date of authorisation: 25/03/2019,, Revision: 1, Authorised, Last updated: 09/12/2021
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Human medicine European public assessment report (EPAR): Viekirax
Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, Revision: 25, Authorised, Last updated: 13/12/2021
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Human medicine European public assessment report (EPAR): Erivedge (updated)
vismodegib, Carcinoma, Basal Cell
Date of authorisation: 12/07/2013,
Date of refusal: 26/04/2013, Revision: 14, Authorised, Last updated: 22/06/2022