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Human medicine European public assessment report (EPAR): Rivaroxaban Accord
rivaroxaban, Acute Coronary Syndrome; Coronary Artery Disease; Peripheral Arterial Disease; Venous Thromboembolism; Stroke; Atrial Fibrillation; Pulmonary Embolism
Date of authorisation: 16/11/2020,
, Revision: 4, Authorised, Last updated: 21/06/2023
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Human medicine European public assessment report (EPAR): Levetiracetam Accord
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 16, Authorised, Last updated: 21/06/2023
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 10, Authorised, Last updated: 20/06/2023
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Human medicine European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira)
voriconazole, Bacterial Infections and Mycoses; Aspergillosis; Candidiasis
Date of authorisation: 27/05/2015,, Revision: 12, Authorised, Last updated: 16/06/2023
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Human medicine European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 26/11/2009,, Revision: 22, Authorised, Last updated: 16/06/2023
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Human medicine European public assessment report (EPAR): Grepid
clopidogrel (as besilate), Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 27/07/2009,, Revision: 26, Authorised, Last updated: 14/06/2023
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Human medicine European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS)
nitisinone, Tyrosinemias
Date of authorisation: 24/08/2017,, Revision: 6, Withdrawn, Last updated: 14/06/2023
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Human medicine European public assessment report (EPAR): Voriconazole Accord
voriconazole, Aspergillosis; Candidiasis; Mycoses
Date of authorisation: 16/05/2013,, Revision: 17, Authorised, Last updated: 14/06/2023
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 15, Authorised, Last updated: 13/06/2023
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 16, Authorised, Last updated: 13/06/2023
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Human medicine European public assessment report (EPAR): Amversio
betaine, Homocystinuria
Date of authorisation: 05/05/2022,, Authorised, Last updated: 08/06/2023
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Human medicine European public assessment report (EPAR): Zonisamide Mylan
zonisamide, Epilepsy
Date of authorisation: 31/03/2016,, Revision: 9, Authorised, Last updated: 08/06/2023
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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: 2, Authorised, Last updated: 07/06/2023
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Human medicine European public assessment report (EPAR): Nityr
nitisinone, Tyrosinemias
Date of authorisation: 26/07/2018,, Revision: 5, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Zoledronic acid Actavis
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
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
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
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): Desloratadine Actavis
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
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): Pioglitazone Actavis
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): Ebilfumin
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): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
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): Sildenafil Actavis
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
topotecan, Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 06/01/2011,, Revision: 11, Authorised, Last updated: 01/06/2023