33 results
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National expert: Monica Bartolomei, Italian Medicines Agency (updated)
- Declaration of interests - 39.46 KB | PDF
- Curriculum Vitae - 33.4 KB | PDF
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National expert: Maria Grazia Evandri, Italian Medicines Agency (updated)
- Declaration of interests - 39.83 KB | PDF
- Curriculum Vitae - 37.07 KB | PDF
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Human medicine European public assessment report (EPAR): SomaKit TOC
edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016,
, Revision: 14, Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): Clopidogrel/Acetylsalicylic acid Teva
clopidogrel, Acetylsalicylic acid, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 01/09/2014, Revision: 1, Withdrawn, Last updated: 28/04/2017 -
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National expert: Rolf Gedeborg, Medical Products Agency (updated)
- Declaration of interests - 40.34 KB | PDF
- Curriculum Vitae - 44.9 KB | PDF
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Referral: Ambroxol and bromhexine-containing medicines
ambroxol, 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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Referral: Pholcodine
pholcodine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/12/2011, EC decision date: 17/02/2012, Last updated: 28/03/2012 -
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National expert: Emilio Perucca, Italian Medicines Agency (updated)
- Declaration of interests - 48.61 KB | PDF
- Curriculum Vitae - 131.22 KB | PDF
TEGGIA DROGHI, M. Studio tossicologico dell'associazione trimethoprim_sulfametossipirazina … -
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National expert: Caridad Pontes, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 41.45 KB | PDF
- Curriculum Vitae - 77.28 KB | PDF
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Referral: Protium
pantoprazole, associated names: Anagastra, Apton, Controloc, Eupantol, Inipomp, Pantec, Pantecta, Pantipp, Panto-Byk-20 / 40 / IV, Pantoc, Pantoloc, PantoLomberg, Pantopan, Pantorc, Pantozol, Peptazol, Rifun, Somac, Ulcotenal, Zurcal, Zurcale, Zurcazol, Article 30 referrals
Status: European Commission final decision, opinion/position date: 17/12/2009, EC decision date: 15/04/2010, Last updated: 17/01/2012 -
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Referral: Terfenadine
terfenadine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/11/1997, EC decision date: 22/09/1998, Last updated: 22/01/1998 -
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Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein for: Treatment of acute myeloid leukaemia
Date of designation: 09/10/2015, Positive, Last updated: 25/04/2022 -
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Orphan designation: Recombinant anti-CD3-bi-single-chain-Fv-diphtheria toxin fusion protein for: Treatment of cutaneous T-cell lymphoma
Date of designation: 09/08/2012, Positive, Last updated: 04/02/2022 -
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Orphan designation: Recombinant anti-CD3-bi-single-chain-Fv-diphtheria toxin fusion protein for: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
Date of designation: 09/08/2012, Positive, Last updated: 04/02/2022 -
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Orphan designation: Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin (tosatoxumab) for: Treatment of pneumonia caused by Staphylococcus aureus
Date of designation: 05/03/2012, Positive, Last updated: 13/07/2021monoclonale umano contro la tossina alfa di Staphylococcus aureus … -
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Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein for: Treatment of blastic plasmacytoid dendritic cell neoplasm
Date of designation: 11/11/2015, Positive, Last updated: 25/01/2021 -
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Orphan designation: Chimeric monoclonal antibody to shiga toxin 1 and 2 for: Treatment of shiga-toxin-producing bacterial infection
Date of designation: 26/08/2005, Positive, Last updated: 12/04/2019 -
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Orphan designation: Carboxypeptidase G2 (glucarpidase) for: Adjunctive treatment in patients at risk of methotrexate toxicity
Date of designation: 03/02/2003, Positive, Last updated: 20/01/2022 -
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Orphan designation: Recombinant modified ricin toxin A-chain subunit for: Prevention of ricin poisoning
Date of designation: 21/03/2018, Positive, Last updated: 08/06/2020Subunità della catena A della tossina della ricina modificata … -
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Orphan designation: Equine immunoglobulin F(ab')2 fragments targeting Shiga toxin for: Prevention of haemolytic uraemic syndrome
Date of designation: 25/05/2018, Positive, Last updated: 24/07/2018 -
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Orphan designation: N,N'-bis(2-mercaptoethyl)isophthalamide (emeramide) for: Treatment of mercury toxicity
Date of designation: 11/01/2012, Positive, Last updated: 16/08/2017 -
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Orphan designation: Emeramide for: Prevention of mercury toxicity
Date of designation: 20/04/2017, Positive, Last updated: 16/08/2017Emeramide Prevenzione della tossicità da mercurio Latvian Emeramīds … Emeramid Prevenzjoni ta’ tossiċità bil-merkurju Polish Emeramid … -
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Orphan designation: Erdosteine for: Treatment of mercury toxicity
Date of designation: 08/11/2012, Positive, Last updated: 13/12/2012Erdosteina Trattamento di tossicità del mercurio Latvian Erdosteīns … Maltese Erdosteine Kura ta’ tossiċità bil-merkurju Polish Erdosteina … -
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Orphan designation: Erdosteine for: Treatment of lead toxicity
Date of designation: 06/12/2012, Positive, Last updated: 25/01/2013Erdosteina Trattamento della tossicità del piombo Latvian Erdosteīns … Maltese Erdosteine Kura ta’ tossiċità biċ-ċomb Polish Erdosteina … -
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Orphan designation: Octavalent Pseudomonas aeruginosa O-polysaccharide-toxin A conjugate for: Prevention of Pseudomonas aeruginosa infections in patients with cystic fibrosis
Date of designation: 11/12/2001, Withdrawn, Last updated: 15/05/2009