14 results
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National expert: Karen De Smet, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 39.19 KB | PDF
- Curriculum Vitae - 32.09 KB | PDF
K, Schuppan D, Yoshida M, Gabbiani G and Geerts A (1998) A … -
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National expert: Mario Miguel Coelho da Silva Rosa, National Authority Of Medicines And Health Products (updated)
- Declaration of interests - 40.13 KB | PDF
- Curriculum Vitae - 67.7 KB | PDF
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Orphan designation: arimoclomol citrate for: Treatment of Niemann-Pick's disease, type C
Date of designation: 19/11/2014, Positive, Last updated: 11/04/2023 -
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Orphan designation: arimoclomol citrate for: Treatment of inclusion body myositis
Date of designation: 18/07/2022, Withdrawn, Last updated: 19/07/2022 -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of designation: 20/06/2017, Withdrawn, Last updated: 03/05/2021acidózis kezelése Italian Citrato di potassio monoidrato e … ārstēšana Lithuanian Trikalio citrato monohidratas su kalio hidrogeno … -
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Orphan designation: sildenafil citrate for: treatment of postcardiotomy right ventricular failure
Date of designation: 26/11/2010, Positive, Last updated: 23/10/2018kezelése Italian Sildenafil citrato Trattamento dell'insufficienza … -
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Orphan designation: Tamoxifen citrate for: Treatment of Duchenne muscular dystrophy
Date of designation: 12/10/2017, Positive, Last updated: 30/07/2019kezelése Italian Tamoxifene citrato Trattamento della distrofia … Duchenne’a Portuguese Citrato de tamoxifeno Tratamento … -
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Orphan designation: sildenafil citrate for: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of designation: 12/12/2003, Expired, Last updated: 19/01/2016αιτιολογίας Italian Sildenafil citrato Trattamento dell’ipertensione … -
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Orphan designation: Lithium citrate tetrahydrate for: Treatment of Huntington’s disease
Date of designation: 28/01/2010, Positive, Last updated: 25/02/2010 -
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Orphan designation: Caffeine citrate for: Prevention of bronchopulmonary dysplasia
Date of designation: 11/04/2014, Positive,dysplasia megelőzése Italian Citrato di caffeina Prevenzione della … -
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Orphan designation: Tamoxifen citrate for: Treatment of cystic fibrosis
Date of designation: 22/05/2017, Positive, Last updated: 29/06/2017 -
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Guidance documents
Last updated: 19/07/2022 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Last updated: 12/09/2022