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]. 

Read Full Article HTML DOI: 10.29328/journal.apps.1001026 Cite this Article Read Full Article PDF


  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
  4. European Medicines Agency . 10-year report to the European commission – General report on the experience acquired as a result of the application of the Paediatric Regulation. 2016. EMA/231225/2015 . https://ec.europa.eu/health/sites/health/files/files/paediatrics/2016_pc_report_2017/ema_10_year_report_for_consultation.pdf
  5. Fabiano V, Mameli C, Zuccotti GV. Paediatric pharmacology: remember the excipients. Pharmacol Res. 2011; 63: 362–365. PubMed: https://pubmed.ncbi.nlm.nih.gov/21241804/
  6. Breikreutz J, Boos J. Paediatric and geriatric drug delivery. Expert Opin Drug Deliv. 2007; 4: 37-45. PubMed: https://pubmed.ncbi.nlm.nih.gov/17184161/
  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/
  10. Ivanovska V, Rademaker CMA, van Dijk L, Mantel-Teeuwisse AK. Pediatric Drug Formulations: A Review of Challenges and Progress. Paediatrics. 2014; 134: 361-372. PubMed: https://pubmed.ncbi.nlm.nih.gov/25022739/

Similar Articles

Recently Viewed

Read More

Most Viewed

Read More

Help ?