45 results
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Veterinary medicine European public assessment report (EPAR): Convenia
cefovecin (as sodium salt), Dogs, Cats
Date of authorisation: 19/06/2006, Revision: 13, Authorised, Last updated: 08/12/2020Prevotella oralis … Bacteroides spp., Prevotella oralis, haemolytic Streptococci … -
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Human medicine European public assessment report (EPAR): Quofenix
delafloxacin meglumine, Skin Diseases, Bacterial
Date of authorisation: 16/12/2019,
, Revision: 2, Authorised, Last updated: 21/12/2020
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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: 17, Authorised, Last updated: 24/02/2021
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National expert: Marco Tuccori, European Medicines Agency (updated)
- Declaration of interests - 79.95 KB | PDF
- Curriculum Vitae - 35.89 KB | PDF
dei nuovi anticoagulanti orali versus gli antagonisti della … -
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Human medicine European public assessment report (EPAR): Hycamtin (updated)
topotecan, Ovarian Neoplasms, Uterine Cervical Neoplasms, Small Cell Lung Carcinoma
Date of authorisation: 12/11/1996, Revision: 32, Authorised, Last updated: 23/02/2021 -
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Human medicine European public assessment report (EPAR): Xydalba (updated)
dalbavancin hydrochloride, Soft Tissue Infections, Skin Diseases, Bacterial
Date of authorisation: 19/02/2015, Revision: 12, Authorised, Last updated: 22/02/2021 -
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Human medicine European public assessment report (EPAR): Ofev
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,
, Revision: 17, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Sivextro
tedizolid phosphate, Soft Tissue Infections, Skin Diseases, Bacterial
Date of authorisation: 23/03/2015, Revision: 13, Authorised, Last updated: 27/11/2020 -
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Human medicine European public assessment report (EPAR): Duaklir Genuair
aclidinium bromide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014,, Revision: 12, Authorised, Last updated: 26/11/2020
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Human medicine European public assessment report (EPAR): Zydelig
Idelalisib, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 18/09/2014,, Revision: 17, Authorised, Last updated: 05/11/2020
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Human medicine European public assessment report (EPAR): Kiovig
human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic, Bone Marrow Transplantation, Immunologic Deficiency Syndromes, Guillain-Barre Syndrome, Mucocutaneous Lymph Node Syndrome
Date of authorisation: 18/01/2006, Revision: 24, Authorised, Last updated: 20/12/2019 -
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Human medicine European public assessment report (EPAR): Vargatef
nintedanib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/11/2014, Revision: 13, Authorised, Last updated: 18/08/2020 -
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Human medicine European public assessment report (EPAR): Pradaxa
Dabigatran etexilate mesilate, Arthroplasty, Replacement, Venous Thromboembolism
Date of authorisation: 17/03/2008,
, Revision: 32, Authorised, Last updated: 19/01/2021
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Human medicine European public assessment report (EPAR): Jinarc
Tolvaptan, Polycystic Kidney, Autosomal Dominant
Date of authorisation: 27/05/2015,, Revision: 14, Authorised, Last updated: 16/04/2020
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Human medicine European public assessment report (EPAR): Sarclisa
Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020,, Authorised, Last updated: 12/06/2020
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Human medicine European public assessment report (EPAR): Brimica Genuair
formoterol fumarate dihydrate, aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014,, Revision: 11, Authorised, Last updated: 29/08/2019
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Human medicine European public assessment report (EPAR): Dutrebis
lamivudine, raltegravir potassium, HIV Infections
Date of authorisation: 26/03/2015, Withdrawn, Last updated: 27/04/2017 -
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Human medicine European public assessment report (EPAR): Rienso
Ferumoxytol, Anemia, Kidney Failure, Chronic
Date of authorisation: 15/06/2012,, Revision: 7, Withdrawn, Last updated: 13/07/2015
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Herbal medicinal product: Andrographidis paniculatae folium
Andrographis paniculata Nees, Kalmegh, F: Assessment finalised, Last updated: 30/04/2018 -
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Referral: Zyrtec
cetirizine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 30/05/2008, EC decision date: 06/10/2008, Last updated: 16/10/2008 -
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Referral: Cevazuril
Toltrazuril, Article 33
Status: European Commission final decision, opinion/position date: 09/12/2009, EC decision date: 26/03/2010, Last updated: 05/05/2010 -
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Referral: Durogesic and associated names
fentanyl, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/07/2016, EC decision date: 22/09/2016, Last updated: 19/10/2016 -
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Orphan designation: Beclomethasone 17, 21-dipropionate for: Treatment of intestinal graft-versus-host disease
Date of first decision: 13/03/2002, Positive, Last updated: 08/06/2020 -
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Referral: Ambroxol and bromhexine-containing medicines
ambroxol and bromhexine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/11/2015, EC decision date: 14/01/2016, Last updated: 05/02/2016 -
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Orphan designation: (Manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21a-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,4,7,10] tetraazacycloheptadecine-κN5, κN13, κN18, κN21, κN22]-) (misopasem manganese) for: Prevention of oral mucositis in head and neck cancer patients undergoing radiation therapy
Date of first decision: 31/01/2008, Positive, Last updated: 17/05/2019