Abstract

Letter to Editor

Criteria for paediatric oral liquid form

Daniela Gavrus, Ferran Bossacoma Busquets*, Josep Maria Català, Joan Lluis Vinent Genestar and Miquel Villaronga Flaque

Published: 26 March, 2021 | Volume 5 - Issue 1 | Pages: 018-019

Paediatric hospitals frequently have to face the lack of commercially available medicines suitable or even licensed for their use in paediatrics. Thus, only one-third of all medicines approved by the European Medicines Agency over the period of 1995 to 2005 were licensed for use in children [1]. 

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References

  1. Ceci A, Felisi M, Baiardi P, Bonifazi F, Catapano M, et al. Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years. Eur J Clin Pharmacol. 2006; 62: 947–952. PubMed: https://pubmed.ncbi.nlm.nih.gov/17021892/
  2. Regulation (EC) No 1901/2006 of the European Parliament and of the Councilof 12 Decembre 2006 on medicinal products for Paediatric use, OJ L 2006; 378:1. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf
  3. World Health Organization. Annex 5. Development of paediatric medicines: points to consider in formulation. World Health Organ Tech Rep Ser. 2012; 970: 197–225. http://apps.who.int/medicinedocs/documents/s19833en/s19833en.pdf
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  7. European Commission. Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668). 2017. https://www.ema.europa.eu/documents/scientific-guideline/annex-european-commission-guideline-excipients-labelling-package-leaflet-medicinal-products-human_en.pdf
  8. European Medicines Agency. Guideline on pharmaceutical development of medicines for paediatric use. EMA. Rev. 2. 2012. https://www.ema.europa.eu/documents/scientific-guideline/draft-guideline-pharmaceutical-development-medicines-paediatric-use_en.pdf
  9. Billstein-Leber M, D Carrillo CJ, Cassano AT, Moline K, Robertson JJ. ASHP Guidelines on Preventing Medication Errors in Hospitals. Am J Health-Syst Pharm. 2018; 75: 1493-517. PubMed: https://pubmed.ncbi.nlm.nih.gov/30257844/
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