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1035 results
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Human medicine European public assessment report (EPAR): Amversio (updated)
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 (updated)
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): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,
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, Revision: 12, Authorised, Last updated: 07/06/2023
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Human medicine European public assessment report (EPAR): Atazanavir Krka (updated)
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): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 20/07/2011,, Revision: 20, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Lacosamide Adroiq (updated)
lacosamide, Epilepsy
Date of authorisation: 31/05/2023,, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Onpattro (updated)
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,, 
, , Revision: 11, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Oxervate (updated)
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,, , , Revision: 2, Authorised, Last updated: 02/06/2023
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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): 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): 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): 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): 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): 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): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (updated)
efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017,, Revision: 15, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan (updated)
sitagliptin hydrochloride monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022,, Revision: 2, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva (updated)
emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016,, Revision: 7, Authorised, Last updated: 30/05/2023