4701 results
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Human medicine European public assessment report (EPAR): Xospata (updated)
gilteritinib fumarate, Leukemia, Myeloid, Acute
Date of authorisation: 24/10/2019,
, 
, Revision: 5, Authorised, Last updated: 07/11/2023
PDF/137.58 KB) (PDF/137.58 KB) Italian (PDF/113.95 KB) (PDF/113.95 … -
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Human medicine European public assessment report (EPAR): Lacosamide UCB (updated)
lacosamide, Epilepsies, Partial
Date of authorisation: 26/08/2019, Revision: 6, Authorised, Last updated: 07/11/2023PDF/151.49 KB) (PDF/151.49 KB) Italian (PDF/125.94 KB) (PDF/125.94 … -
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Human medicine European public assessment report (EPAR): PreHevbri (updated)
hepatitis B surface antigen, Hepatitis B
Date of authorisation: 25/04/2022,, Revision: 2, Authorised, Last updated: 07/11/2023
PDF/133.62 KB) (PDF/133.62 KB) Italian (PDF/111.85 KB) (PDF/111.85 … -
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Human medicine European public assessment report (EPAR): Mozobil (updated)
Plerixafor, Multiple Myeloma; Hematopoietic Stem Cell Transplantation; Lymphoma
Date of authorisation: 30/07/2009, Revision: 23, Authorised, Last updated: 06/11/2023PDF/106.7 KB) (PDF/106.7 KB) Italian (PDF/83.89 KB) (PDF/83.89 … -
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Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma) (updated)
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,, , Revision: 4, Authorised, Last updated: 06/11/2023
PDF/115.93 KB) (PDF/115.93 KB) Italian (PDF/93.04 KB) (PDF/93.04 … -
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Human medicine European public assessment report (EPAR): Pioglitazone Teva Pharma
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012,
, Revision: 13, Withdrawn, Last updated: 30/08/2022
PDF/766.16 KB) (PDF/766.16 KB) Italian (PDF/696.38 KB) (PDF/696.38 … -
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Human medicine European public assessment report (EPAR): Emselex
darifenacin hydrobromide, Urinary Incontinence, Urge; Urinary Bladder, Overactive
Date of authorisation: 22/10/2004, Revision: 26, Authorised, Last updated: 27/10/2023PDF/101.15 KB) (PDF/101.15 KB) Italian (PDF/80.42 KB) (PDF/80.42 … -
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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
PDF/694.79 KB) (PDF/694.79 KB) Italian (PDF/644.63 KB) (PDF/644.63 … -
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Human medicine European public assessment report (EPAR): Vitrakvi
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, 
, Revision: 10, Authorised, Last updated: 22/09/2023
PDF/91.91 KB) (PDF/91.91 KB) Italian (PDF/72.68 KB) (PDF/72.68 … -
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Human medicine European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius) (updated)
carmustine, Hodgkin Disease; Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018,, Revision: 9, Authorised, Last updated: 24/11/2023
PDF/185.28 KB) (PDF/185.28 KB) Italian (PDF/159.14 KB) (PDF/159.14 … -
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Human medicine European public assessment report (EPAR): Fingolimod Mylan (updated)
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 18/08/2021,, Revision: 5, Authorised, Last updated: 20/11/2023
PDF/164.71 KB) (PDF/164.71 KB) Italian (PDF/140.83 KB) (PDF/140.83 … -
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Human medicine European public assessment report (EPAR): Pemetrexed Lilly
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 14/09/2015,, Revision: 7, Withdrawn, Last updated: 26/11/2021
PDF/723.57 KB) (PDF/723.57 KB) Italian (PDF/660.44 KB) (PDF/660.44 … -
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Human medicine European public assessment report (EPAR): Telmisartan Teva
Telmisartan, Hypertension
Date of authorisation: 25/01/2010,, Revision: 11, Withdrawn, Last updated: 17/09/2021
PDF/1.27 MB) (PDF/1.27 MB) Italian (PDF/1.2 MB) (PDF/1.2 MB … formally requested by the Italian medicines agency, to examine … -
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Human medicine European public assessment report (EPAR): Azilect
rasagiline, Parkinson Disease
Date of authorisation: 21/02/2005, Revision: 23, Authorised, Last updated: 18/08/2023PDF/96.68 KB) (PDF/96.68 KB) Italian (PDF/75.07 KB) (PDF/75.07 … -
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Human medicine European public assessment report (EPAR): Buvidal
buprenorphine, Opioid-Related Disorders
Date of authorisation: 20/11/2018, Revision: 8, Authorised, Last updated: 16/08/2023PDF/113.76 KB) (PDF/113.76 KB) Italian (PDF/93.18 KB) (PDF/93.18 … -
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Human medicine European public assessment report (EPAR): Aerius
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 50, Authorised, Last updated: 02/08/2023PDF/96.11 KB) (PDF/96.11 KB) Italian (PDF/97.71 KB) (PDF/97.71 … -
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Human medicine European public assessment report (EPAR): Darunavir Krka d.d.
darunavir, HIV Infections
Date of authorisation: 18/01/2018,, Revision: 8, Withdrawn, Last updated: 03/02/2023
PDF/722.62 KB) (PDF/722.62 KB) Italian (PDF/663.19 KB) (PDF/663.19 … -
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm GmbH
clopidogrel, Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/07/2009,, Revision: 12, Withdrawn, Last updated: 25/01/2021
PDF/748.24 KB) (PDF/748.24 KB) Italian (PDF/736.11 KB) (PDF/736.11 … -
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Human medicine European public assessment report (EPAR): Fotivda
tivozanib, Carcinoma, Renal Cell
Date of authorisation: 24/08/2017,, Revision: 9, Authorised, Last updated: 17/07/2023
PDF/90.4 KB) (PDF/90.4 KB) Italian (PDF/72.18 KB) (PDF/72.18 … -
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Human medicine European public assessment report (EPAR): Pemetrexed Accord
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 10, Authorised, Last updated: 27/10/2023
PDF/117.8 KB) (PDF/117.8 KB) Italian (PDF/97.6 KB) (PDF/97.6 KB … -
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Human medicine European public assessment report (EPAR): Enyglid
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 13/10/2009,, Revision: 9, Authorised, Last updated: 14/12/2022
PDF/91.79 KB) (PDF/91.79 KB) Italian (PDF/72 KB) (PDF/72 KB) Latvian … -
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Human medicine European public assessment report (EPAR): Bortezomib Hospira
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 13, Authorised, Last updated: 09/10/2023
PDF/116.32 KB) (PDF/116.32 KB) Italian (PDF/98.25 KB) (PDF/98.25 … -
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Human medicine European public assessment report (EPAR): Vydura
Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022,, Revision: 5, Authorised, Last updated: 05/06/2023
PDF/138.05 KB) (PDF/138.05 KB) Italian (PDF/117.4 KB) (PDF/117.4 … -
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Human medicine European public assessment report (EPAR): Ogluo
Glucagon, Diabetes Mellitus
Date of authorisation: 11/02/2021, Revision: 5, Authorised, Last updated: 26/05/2023PDF/154.15 KB) (PDF/154.15 KB) Italian (PDF/131.28 KB) (PDF/131.28 … -
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Human medicine European public assessment report (EPAR): Circadin
melatonin, Sleep Initiation and Maintenance Disorders
Date of authorisation: 29/06/2007, Revision: 34, Authorised, Last updated: 17/05/2023PDF/144.38 KB) (PDF/144.38 KB) Italian (PDF/127.02 KB) (PDF/127.02 …