145 results
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Human medicine European public assessment report (EPAR): Valdoxan
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009, Revision: 24, Authorised, Last updated: 08/08/2022 -
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Human medicine European public assessment report (EPAR): Cibinqo
Abrocitinib, Dermatitis, Atopic
Date of authorisation: 09/12/2021,
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, Revision: 3, Authorised, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Ribavirin Teva Pharma B.V.
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 01/07/2009,
, Revision: 14, Withdrawn, Last updated: 09/07/2021
Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide … that markets Fenofibrato Pensa and Fenofibrato Ranbaxy … should); Fenofibrato Pensa and Fenofibrato Ranbaxy … -
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Human medicine European public assessment report (EPAR): Xospata
gilteritinib fumarate, Leukemia, Myeloid, Acute
Date of authorisation: 24/10/2019,, 
, Revision: 3, Authorised, Last updated: 20/05/2022
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Human medicine European public assessment report (EPAR): Methylthioninium chloride Proveblue
methylthioninium chloride, Methemoglobinemia
Date of authorisation: 06/05/2011, Revision: 25, Authorised, Last updated: 15/12/2022 -
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022,, Revision: 6, Authorised, Last updated: 04/04/2023
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Human medicine European public assessment report (EPAR): Aloxi
palonosetron hydrochloride, Vomiting; Cancer
Date of authorisation: 22/03/2005, Revision: 22, Authorised, Last updated: 24/02/2023 -
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Human medicine European public assessment report (EPAR): Aripiprazole Zentiva
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 25/06/2015,, Revision: 9, Authorised, Last updated: 26/08/2022
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Human medicine European public assessment report (EPAR): Zoely
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 26/07/2011, Revision: 23, Authorised, Last updated: 16/02/2023 -
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Human medicine European public assessment report (EPAR): Palonosetron Hospira
palonosetron hydrochloride, Nausea; Vomiting; Cancer
Date of authorisation: 08/04/2016,, Revision: 4, Withdrawn, Last updated: 08/04/2022
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National expert: Leonard van den Berg, European Medicines Agency (updated)
- Declaration of interests - 48.55 KB | PDF
- Curriculum Vitae - 41.63 KB | PDF
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Human medicine European public assessment report (EPAR): Aripiprazole Sandoz
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 20/08/2015,, Revision: 9, Authorised, Last updated: 01/09/2022
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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): Tamiflu
oseltamivir, Influenza, Human
Date of authorisation: 20/06/2002, Revision: 42, Authorised, Last updated: 24/03/2023 -
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Human medicine European public assessment report (EPAR): Zubsolv
Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 10/11/2017, Revision: 8, Authorised, Last updated: 29/07/2022 -
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Human medicine European public assessment report (EPAR): Palonosetron Accord
Palonosetron, Vomiting; Nausea; Cancer
Date of authorisation: 26/05/2016,, Revision: 5, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Aripiprazole Accord
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 15, Authorised, Last updated: 13/07/2022
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Human medicine European public assessment report (EPAR): Yentreve
duloxetine hydrochloride, Urinary Incontinence, Stress
Date of authorisation: 11/08/2004, Revision: 28, Authorised, Last updated: 21/12/2021paroxetine, citalopram, escitalopram, atomoxetine, duloxetine … -
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Human medicine European public assessment report (EPAR): Abilify
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 04/06/2004, Revision: 49, Authorised, Last updated: 08/04/2022 -
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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): Spikevax (previously COVID-19 Vaccine Moderna)
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: 36, Authorised, Last updated: 12/04/2023
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Human medicine European public assessment report (EPAR): Rinvoq
upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019,, , Revision: 14, Authorised, Last updated: 24/04/2023
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Human medicine European public assessment report (EPAR): Buvidal
buprenorphine, Opioid-Related Disorders
Date of authorisation: 20/11/2018, Revision: 6, Authorised, Last updated: 21/10/2021 -
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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): Incivo
telaprevir, Hepatitis C, Chronic
Date of authorisation: 19/09/2011,, Revision: 19, Withdrawn, Last updated: 06/10/2016