Off-label is not always off-evidence: authorising paediatric indications for old medicines.

de Wildt, Saskia N; Foeldvari, Ivan; Siapkara, Angeliki; Lepola, Pirkko; Kriström, Berit; Ruggieri, Lucia; Eichler, Irmgard; Egger, Gunter F

de Wildt, Saskia N; Foeldvari, Ivan; Siapkara, Angeliki; Lepola, Pirkko; Kriström, Berit; Ruggieri, Lucia; Eichler, Irmgard; Egger, Gunter F.

Afiliação

de Wildt SN; Department of Pharmacology and Toxicology, Radboud Institute of Health Sciences, Radboud University Medical Center, Nijmegen 6500, Netherlands; Intensive Care and Department of Paediatric Surgery, Erasmus MC Sophia Children's Hospital, Rotterdam, Netherlands. Electronic address: saskia.dewildt@radbo
Foeldvari I; Hamburger Centrum for Paediatric and Adolescent Rheumatology and Centre for Treatment of Scleroderma and Uveitis in Childhood and Adolescence, An der Schön Klinik Hamburg Eilbek, Hamburg, Germany; Teaching Unit of the Asklepios Campus, Semmelweis Medical School, Budapest, Hungary.
Siapkara A; Medicines and Healthcare Products Regulatory Agency (MHRA), Paediatrics, Innovative Medicines, London, UK.
Lepola P; Department of Children and Adolescents, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Kriström B; Paediatrics Unit, Institute of Clinical Science, Umeå University, Umeå, Sweden.
Ruggieri L; Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Bari, Italy; TEDDY European Network of Excellence for Paediatric Research, Pavia, Italy.
Eichler I; European Medicines Agency (EMA), Amsterdam, Netherlands.
Egger GF; European Medicines Agency (EMA), Amsterdam, Netherlands.

Lancet Child Adolesc Health ; 7(6): 371-372, 2023 06.

Article em En | MEDLINE | ID: mdl-37116529

Assuntos

Aprovação de Drogas; Uso Off-Label; Criança; Humanos

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Aprovação de Drogas / Uso Off-Label Limite: Child / Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article

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