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2013 results
Medicine
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Human medicine European public assessment report (EPAR): Zoledronic acid Actavis (updated)
zoledronic acid monohydrate, Fractures, Bone
Date of authorisation: 20/04/2012,
, Revision: 15, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Telmisartan Actavis (updated)
Telmisartan, Hypertension
Date of authorisation: 29/09/2010,, Revision: 12, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Tadalafil Mylan (updated)
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,, Revision: 15, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Actelsar HCT (updated)
Telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013,, Revision: 15, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Levetiracetam Actavis Group (updated)
levetiracetam, Epilepsy
Date of authorisation: 04/12/2011,, Revision: 17, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Desloratadine Actavis (updated)
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 13/01/2012,, Revision: 16, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Vildagliptin / Metformin hydrochloride Accord (updated)
metformin hydrochloride, vildagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 24/03/2022,
, , Revision: 2, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Kentera (previously Oxybutynin Nicobrand) (updated)
oxybutynin, Urinary Incontinence, Urge
Date of authorisation: 15/06/2004, Revision: 21, Authorised, Last updated: 01/06/2023 -
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Human medicine European public assessment report (EPAR): Empliciti (updated)
Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016,
, Revision: 12, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Pioglitazone Actavis (updated)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/03/2012,, Revision: 9, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Armisarte (previously Pemetrexed Actavis) (updated)
pemetrexed diacid monohydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016, Revision: 13, Authorised, Last updated: 01/06/2023 -
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Human medicine European public assessment report (EPAR): Ebilfumin (updated)
oseltamivir, Influenza, Human
Date of authorisation: 22/05/2014,, Revision: 15, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Rebif (updated)
interferon beta-1a, Multiple Sclerosis
Date of authorisation: 03/05/1998, Revision: 41, Authorised, Last updated: 01/06/2023 -
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Human medicine European public assessment report (EPAR): Adynovi (updated)
rurioctocog alfa pegol, Hemophilia A
Date of authorisation: 08/01/2018,, Revision: 9, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (updated)
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,, Revision: 10, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Benepali (updated)
etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis
Date of authorisation: 13/01/2016,
, Revision: 20, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Rapilysin (updated)
reteplase, Myocardial Infarction
Date of authorisation: 29/08/1996, Revision: 27, Authorised, Last updated: 01/06/2023 -
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Human medicine European public assessment report (EPAR): Sildenafil Actavis (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009,, Revision: 16, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Potactasol (updated)
topotecan, Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 06/01/2011,, Revision: 11, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Gilenya (updated)
fingolimod hydrochloride , Multiple Sclerosis
Date of authorisation: 17/03/2011, Revision: 35, Authorised, Last updated: 01/06/2023 -
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Human medicine European public assessment report (EPAR): Vemlidy (updated)
tenofovir alafenamide fumarate, Hepatitis B
Date of authorisation: 09/01/2017, Revision: 16, Authorised, Last updated: 31/05/2023 -
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Human medicine European public assessment report (EPAR): Dabigatran Etexilate Accord (updated)
Dabigatran etexilate mesilate, Venous Thromboembolism; Arthroplasty, Replacement
Date of authorisation: 26/05/2023,, Authorised, Last updated: 31/05/2023
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Human medicine European public assessment report (EPAR): Epysqli (updated)
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 26/05/2023,, , Authorised, Last updated: 31/05/2023
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Human medicine European public assessment report (EPAR): Pergoveris (updated)
follitropin alfa, lutropin alfa, Infertility, Female
Date of authorisation: 25/06/2007, Revision: 15, Authorised, Last updated: 31/05/2023 -
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
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: 37, Authorised, Last updated: 31/05/2023