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539 results
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Referral: Zinbryta
associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, EC decision date: 27/03/2018, Last updated: 11/07/2018 -
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Referral: Zinbryta
daclizumab, associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, opinion/position date: 09/11/2017, EC decision date: 08/01/2018, Last updated: 12/01/2018 -
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Orphan designation: Masitinib mesilate for: Treatment of pancreatic cancer
Date of designation: 28/10/2009, Positive, -
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Orphan designation: Caffeine citrate for: Prevention of bronchopulmonary dysplasia
Date of designation: 11/04/2014, Positive, -
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Orphan designation: 1,3-Propanedisulfonic acid, disodium salt for: Treatment of systemic secondary amyloidosis
Date of designation: 31/07/2001, Positive, -
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Orphan designation: Fluocinolone acetonide for: Treatment of non-infectious uveitis affecting the posterior segment of the eye
Date of designation: 07/03/2005, Positive, Last updated: 30/05/2007 -
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Orphan designation: Mepolizumab for: Treatment of hypereosinophilic syndrome
Date of designation: 29/07/2004, Withdrawn, Last updated: 23/10/2020 -
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Orphan designation: Taliglucerase alfa for: Treatment of Gaucher disease
Date of designation: 23/03/2010, Positive, Last updated: 10/03/2011 -
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Orphan designation: Human heterologous liver cells for: Treatment of argininosuccinic aciduria
Date of designation: 17/12/2010, Positive, Last updated: 16/08/2016 -
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Orphan designation: Ivosidenib for: Treatment of acute myeloid leukaemia
Date of designation: 12/12/2016, Positive, Last updated: 08/06/2021 -
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Orphan designation: Human heterologous liver cells for: Treatment of carbamoyl-phosphate synthase-1 deficiency
Date of designation: 17/12/2010, Positive, Last updated: 16/08/2016 -
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Orphan designation: Sirolimus for: Treatment of chronic non-infectious uveitis
Date of designation: 30/08/2011, Positive, Last updated: 21/09/2011 -
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Orphan designation: Aplidine for: Treatment of multiple myeloma
Date of designation: 16/11/2004, Positive, Last updated: 11/10/2005 -
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Orphan designation: Autologous Tumor-Derived gp96 Heat Shock Protein-Peptide Complex for: Treatment of renal-cell carcinoma
Date of designation: 11/04/2005, Positive, Last updated: 04/01/2006 -
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Orphan designation: Mercaptopurine for: Treatment of acute lymphoblastic leukaemia
Date of designation: 22/10/2007, Positive, Last updated: 22/01/2014 -
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Orphan designation: Sodium benzoate for: Treatment of carbamoyl-phosphate synthase-1 deficiency
Date of designation: 14/07/2016, Positive, Last updated: 06/09/2016 -
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Orphan designation: 27000 for: Treatment of post-essential thrombocythaemia myelofibrosis
Date of designation: 25/08/2010, Positive, Last updated: 29/03/2016 -
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Orphan designation: 27000 for: Treatment of primary myelofibrosis
Date of designation: 25/08/2010, Positive, Last updated: 29/03/2016 -
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Orphan designation: Sodium benzoate for: Treatment of hyperargininaemia
Date of designation: 14/07/2016, Positive, Last updated: 06/09/2016 -
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Orphan designation: Sodium benzoate for: Treatment of lysinuric protein intolerance
Date of designation: 29/08/2016, Positive, Last updated: 03/10/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Rienso, Ferumoxytol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000373-PIP02-09-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 01/04/2015, Last updated: 06/05/2015, Compliance check: X -
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Orphan designation: Gusperimus trihydrochloride for: Treatment of Wegener's granulomatosis
Date of designation: 29/03/2001, Positive, Last updated: 18/11/2011 -
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Orphan designation: Cysteamine hydrochloride for: Treatment of cystinosis
Date of designation: 15/10/2014, Positive, Last updated: 12/11/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Pumarix, Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005(H5N1) like strain used (PR8-IBCDC-RG2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000178-PIP01-07-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 08/05/2015, Last updated: 15/06/2015, Compliance check: X -
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Orphan designation: Ethyl Eicosapentaenoate for: Treatment of Huntington’s disease
Date of designation: 29/12/2000, Positive, Last updated: 04/01/2006