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Paediatric medicines development for Duchenne muscular dystrophy: An EU regulatory perspective.

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Title: Paediatric medicines development for Duchenne muscular dystrophy: An EU regulatory perspective.
Authors: Benchetrit S; Department of Europe and Innovation, Agence nationale de sécurité du médicament et des produits de santé (ANSM), Saint-Denis, France., Chu C; Department of Europe and Innovation, Agence nationale de sécurité du médicament et des produits de santé (ANSM), Saint-Denis, France., Athanasiou D; World Duchenne Organization, Veenendaal, The Netherlands., Scherer S; Paediatric and Orphan Medicinal Products Unit, Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany., de Andres Trelles F; Departamento de Farmacología y Toxicología, Universidad Complutense, Madrid, Spain., Stoyanova-Beninska V; European Medicines Agency (EMA), Amsterdam, The Netherlands., Martinez-Lapiscina EH; European Medicines Agency (EMA), Amsterdam, The Netherlands., De Lisa R; European Medicines Agency (EMA), Amsterdam, The Netherlands.
Source: Journal of neuromuscular diseases [J Neuromuscul Dis] 2026 May; Vol. 13 (3), pp. 405-419. Date of Electronic Publication: 2025 Nov 18.
Publication Type: Journal Article; Review
Journal Info: Publisher: IOS Press Country of Publication: United States NLM ID: 101649948 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2214-3602 (Electronic) Linking ISSN: 22143599 NLM ISO Abbreviation: J Neuromuscul Dis Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Paediatric medicines development for Duchenne muscular dystrophy: An EU regulatory perspective.
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  Data: <searchLink fieldCode="AU" term="%22Benchetrit+S%22">Benchetrit S</searchLink>; Department of Europe and Innovation, Agence nationale de sécurité du médicament et des produits de santé (ANSM), Saint-Denis, France.<br /><searchLink fieldCode="AU" term="%22Chu+C%22">Chu C</searchLink>; Department of Europe and Innovation, Agence nationale de sécurité du médicament et des produits de santé (ANSM), Saint-Denis, France.<br /><searchLink fieldCode="AU" term="%22Athanasiou+D%22">Athanasiou D</searchLink>; World Duchenne Organization, Veenendaal, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Scherer+S%22">Scherer S</searchLink>; Paediatric and Orphan Medicinal Products Unit, Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.<br /><searchLink fieldCode="AU" term="%22de+Andres+Trelles+F%22">de Andres Trelles F</searchLink>; Departamento de Farmacología y Toxicología, Universidad Complutense, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Stoyanova-Beninska+V%22">Stoyanova-Beninska V</searchLink>; European Medicines Agency (EMA), Amsterdam, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Martinez-Lapiscina+EH%22">Martinez-Lapiscina EH</searchLink>; European Medicines Agency (EMA), Amsterdam, The Netherlands.<br /><searchLink fieldCode="AU" term="%22De+Lisa+R%22">De Lisa R</searchLink>; European Medicines Agency (EMA), Amsterdam, The Netherlands.
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  Data: <searchLink fieldCode="JN" term="%22101649948%22">Journal of neuromuscular diseases</searchLink> [J Neuromuscul Dis] 2026 May; Vol. 13 (3), pp. 405-419. <i>Date of Electronic Publication: </i>2025 Nov 18.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22IOS+Press%22">IOS Press </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101649948 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2214-3602 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2222143599%22">22143599 </searchLink><i>NLM ISO Abbreviation: </i>J Neuromuscul Dis <i>Subsets: </i>MEDLINE
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        Value: 10.1177/22143602251397736
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              Text: 2026 May
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