37 results
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National expert: Angela Del Vecchio, Italian Medicines Agency (updated)
- Declaration of interests - 39.72 KB | PDF
- Curriculum Vitae - 28.31 KB | PDF
Vecchio A. Le Procedure per il rilascio dell’esenzione dagli accertamenti … -
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National expert: Federica Chiara, European Medicines Agency (updated)
- Declaration of interests - 40.15 KB | PDF
- Curriculum Vitae - 206.71 KB | PDF
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Orphan designation: hydrocortisone for: Treatment of adrenal insufficiency
Date of designation: 22/05/2006, Expired, Last updated: 25/11/2021 -
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia
Date of designation: 27/07/2005, Positive, Last updated: 14/06/2021 -
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Referral: Losec
omeprazole, associated names: Antra, Logastric, Losec Forte, Mopral, Omeprazen, Omeprazole, AstraZeneca, Zoltum, Article 30 referrals
Status: European Commission final decision, opinion/position date: 20/01/2010, EC decision date: 10/06/2010, Last updated: 19/09/2011 -
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Orphan designation: dexamethasone for: Treatment of multiple myeloma
Date of designation: 09/06/2010, Withdrawn, Last updated: 12/02/2018kezelése Italian Desametasone (compressa da 40 mg) Trattamento del … -
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Referral: Plendil and associated names
felodipine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 16/12/2014, Last updated: 30/03/2015 -
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Orphan designation: Modified mRNA encoding human methylmalonyl-coenzyme A mutase encapsulated into lipid nanoparticles for: Treatment of methylmalonic acidaemia
Date of designation: 25/05/2018, Withdrawn, Last updated: 26/06/2023 -
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Referral: Seroquel XR
quetiapine, Article 6(13) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 22/04/2010, EC decision date: 26/08/2010, Last updated: 19/11/2010 -
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Orphan designation: Recombinant human factor IX protein modified with three point mutations (dalcinonacog alfa) for: Treatment of haemophilia B
Date of designation: 20/06/2017, Positive, Last updated: 03/08/2023 -
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Referral: Seroquel / Seroquel XR and associated names
quetiapine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 06/08/2014, Last updated: 09/09/2014 -
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Orphan designation: genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII (beremagene geperpavec) for: Treatment of epidermolysis bullosa
Date of designation: 16/04/2018, Positive, Last updated: 10/11/2022 -
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Orphan designation: Modified mRNA encoding the UGT1A1 protein for: Treatment of Crigler-Najjar syndrome
Date of designation: 27/06/2016, Positive, Last updated: 14/09/2022 -
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Orphan designation: Recombinant modified human growth hormone for: Treatment of growth hormone deficiency
Date of designation: 24/01/2013, Positive, Last updated: 03/03/2022crescita umano ricombinante, modificato Per il trattamento del … -
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Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide) for: Treatment of achondroplasia
Date of designation: 24/01/2013, Positive, Last updated: 09/09/2021 -
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Orphan designation: Recombinant factor VIIa modified with three terminal repeats derived from the β chain of human chorionic gonadotropin for: Treatment of haemophilia B
Date of designation: 22/08/2014, Positive, Last updated: 16/09/2021 -
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Orphan designation: Recombinant factor VIIa modified with three terminal repeats derived from the β chain of human chorionic gonadotropin for: Treatment of haemophilia A
Date of designation: 22/08/2014, Positive, Last updated: 16/09/2021 -
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Orphan designation: Recombinant factor VIIa modified with three terminal repeats derived from the β chain of human chorionic gonadotropin for: Treatment of congenital factor VII deficiency
Date of designation: 22/08/2014, Positive, Last updated: 16/09/2021 -
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Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for: Treatment of malignant mesothelioma
Date of designation: 16/12/2014, Positive, Last updated: 19/03/2021 -
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Orphan designation: genetically modified serotype 5/3 adenovirus coding for granulocyte-macrophage colony-stimulating factor for: Treatment of soft tissue sarcoma
Date of designation: 19/06/2013, Positive, Last updated: 19/03/2021 -
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Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for the treatment of ovarian cancer for: Treatment of ovarian cancer
Date of designation: 29/04/2014, Positive, Last updated: 19/03/2021 -
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Orphan designation: Modified messenger ribonucleic acid encoding human ornithine transcarbamylase enzyme encapsulated into lipid nanoparticles for: Treatment of ornithine transcarbamylase deficiency
Date of designation: 20/04/2017, Positive, Last updated: 15/05/2017 -
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Orphan designation: Synthetic glucagon analogue modified to contain 7 amino acid substitutions for: Treatment of congenital hyperinsulinism
Date of designation: 20/06/2017, Positive, Last updated: 25/09/2020sintetico del glucagone, modificato con sette sostituzioni aminoacidiche … -
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Orphan designation: Modified adenovirus serotype 5/35 containing a CMV promoter-driven transgene cassette with the human transgenes for a membrane-bound CD40 ligand and full length 4-1BBL for: Treatment of pancreatic cancer
Date of designation: 28/07/2015, Positive, Last updated: 11/06/2020 -
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Orphan designation: Recombinant modified vaccinia Ankara expressing human 5T4 for: Treatment of renal-cell carcinoma
Date of designation: 26/01/2007, Positive, Last updated: 04/12/2007