166 results
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Human medicine European public assessment report (EPAR): Darunavir Mylan
darunavir, HIV Infections
Date of authorisation: 03/01/2017,
, Revision: 13, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Darunavir Krka
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 10, Authorised, Last updated: 15/05/2023
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Human medicine European public assessment report (EPAR): Evotaz
cobicistat, atazanavir, HIV Infections
Date of authorisation: 13/07/2015, Revision: 14, Authorised, Last updated: 25/04/2023 -
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Human medicine European public assessment report (EPAR): Tybost
cobicistat, HIV Infections
Date of authorisation: 19/09/2013, Revision: 15, Authorised, Last updated: 14/02/2023 -
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Human medicine European public assessment report (EPAR): Symtuza
darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/09/2017, Revision: 17, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Darunavir Krka d.d.
darunavir, HIV Infections
Date of authorisation: 18/01/2018,, Revision: 8, Withdrawn, Last updated: 03/02/2023
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Human medicine European public assessment report (EPAR): Prezista
darunavir, HIV Infections
Date of authorisation: 11/02/2007, Revision: 54, Authorised, Last updated: 03/03/2023 -
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Human medicine European public assessment report (EPAR): Evra
norelgestromin, Ethinyl estradiol, Contraception
Date of authorisation: 22/08/2002, Revision: 25, Authorised, Last updated: 09/11/2022chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene … chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene … -
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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: 30, Authorised, Last updated: 21/09/2023
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Human medicine European public assessment report (EPAR): Rezolsta
darunavir, cobicistat, HIV Infections
Date of authorisation: 19/11/2014, Revision: 15, Authorised, Last updated: 13/12/2022 -
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Human medicine European public assessment report (EPAR): Stribild
elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 24/05/2013, Revision: 25, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Genvoya
elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 19/11/2015, Revision: 27, Authorised, Last updated: 28/11/2022 -
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Human medicine European public assessment report (EPAR): Veltassa
patiromer sorbitex calcium, Hyperkalemia
Date of authorisation: 19/07/2017, Revision: 7, Authorised, Last updated: 03/04/2023 -
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Human medicine European public assessment report (EPAR): Biktarvy
bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections
Date of authorisation: 21/06/2018, Revision: 16, Authorised, Last updated: 28/04/2023 -
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Human medicine European public assessment report (EPAR): Ryeqo
relugolix, norethisterone acetate, estradiol hemihydrate, Leiomyoma
Date of authorisation: 16/07/2021,, Revision: 5, Authorised, Last updated: 08/06/2023
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Human medicine European public assessment report (EPAR): Victrelis
Boceprevir, Hepatitis C, Chronic
Date of authorisation: 18/07/2011, Revision: 22, Withdrawn, Last updated: 31/07/2018 -
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Human medicine European public assessment report (EPAR): Ioa
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 16/11/2011, Revision: 4, Withdrawn, Last updated: 26/08/2014contraceptive pill containing drospirenone and ethinyl estradiol for … desogestrel, dienogest, drospirenone, etonogestrel, gestodene … -
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Referral: Dienogest/ethinylestradiol-containing medicinal products indicated in acne
dienogest, ethinyl estradiol, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/01/2017, EC decision date: 22/03/2017, Last updated: 24/03/2017 -
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Referral: Seasonique and associated names
levonorgestrel, ethinylestradiol, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/11/2014, EC decision date: 12/01/2015, Last updated: 29/01/2015 -
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Referral: Nomegestrol and chlormadinone
nomegestrol, chlormadinone, associated names: Zoely, Article 31 referrals
Status: European Commission final decision, opinion/position date: 01/09/2022, EC decision date: 28/11/2022, Last updated: 14/12/2022 -
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List of medicines under additional monitoring (updated)
Last updated: 26/09/2023 -
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Public data from Article 57 database
Last updated: 30/06/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 25/09/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 June 2023 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 05/06/2023 to 08/06/2023, Last updated: 04/09/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 11/04/2023 to 14/04/2023, Last updated: 07/07/2023