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Medicine
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Human medicine European public assessment report (EPAR): MicardisPlus (updated)
telmisartan, hydrochlorothiazide, Hypertension
Date of authorisation: 19/04/2002, Revision: 33, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva (updated)
lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011,, Revision: 16, Withdrawn, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Vihuma (updated)
simoctocog alfa, Hemophilia A
Date of authorisation: 13/02/2017,, Revision: 8, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Nuwiq (updated)
simoctocog alfa, Hemophilia A
Date of authorisation: 22/07/2014, Revision: 13, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Beyfortus (updated)
nirsevimab,
Date of authorisation: 31/10/2022,, Revision: 1, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Elocta (updated)
efmoroctocog alfa, Hemophilia A
Date of authorisation: 18/11/2015, Revision: 12, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Inrebic (updated)
fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders; Primary Myelofibrosis
Date of authorisation: 08/02/2021,,
, Revision: 4, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Vydura (updated)
Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022,, Revision: 4, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 12, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Revatio (updated)
sildenafil, Hypertension, Pulmonary
Date of authorisation: 28/10/2005, Revision: 49, Authorised, Last updated: 21/03/2023 -
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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: 17, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Ecalta (updated)
anidulafungin, Candidiasis
Date of authorisation: 20/09/2007, Revision: 24, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Lucentis (updated)
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetes Complications; Myopia, Degenerative
Date of authorisation: 22/01/2007, Revision: 41, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Nevirapine Teva (updated)
nevirapine, HIV Infections
Date of authorisation: 30/11/2009,, Revision: 11, Withdrawn, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Imvanex (updated)
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013,,
, Revision: 24, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Aldara (updated)
imiquimod, Condylomata Acuminata; Keratosis; Keratosis, Actinic; Carcinoma, Basal Cell
Date of authorisation: 18/09/1998, Revision: 30, Authorised, Last updated: 20/03/2023 -
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Human medicine European public assessment report (EPAR): Alkindi (updated)
hydrocortisone, Adrenal Insufficiency
Date of authorisation: 09/02/2018, Revision: 8, Authorised, Last updated: 20/03/2023 -
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Human medicine European public assessment report (EPAR): Zomarist (updated)
vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 30/11/2008, Revision: 23, Authorised, Last updated: 20/03/2023 -
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Human medicine European public assessment report (EPAR): Mircera (updated)
Methoxy polyethylene glycol-epoetin beta, Anemia; Kidney Failure, Chronic
Date of authorisation: 20/07/2007, Revision: 28, Authorised, Last updated: 20/03/2023 -
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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: 15, Authorised, Last updated: 20/03/2023 -
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Human medicine European public assessment report (EPAR): Reblozyl (updated)
Luspatercept, Anemia; Myelodysplastic Syndromes; beta-Thalassemia
Date of authorisation: 25/06/2020,,
, Revision: 4, Authorised, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Nubeqa (updated)
darolutamide, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 27/03/2020,, Revision: 4, Authorised, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Isturisa (updated)
Osilodrostat phosphate, Cushing Syndrome
Date of authorisation: 09/01/2020,,
, Revision: 4, Authorised, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Docetaxel Accord (updated)
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 16, Authorised, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Pregabalin Pfizer (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 10/04/2014, Revision: 29, Authorised, Last updated: 20/03/2023