{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T19:49:29Z","timestamp":1791575369080,"version":"4.3.4"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2014,6,5]],"date-time":"2014-06-05T00:00:00Z","timestamp":1401926400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springer.com\/tdm"},{"start":{"date-parts":[[2014,6,5]],"date-time":"2014-06-05T00:00:00Z","timestamp":1401926400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pediatr Drugs"],"published-print":{"date-parts":[[2014,8]]},"DOI":"10.1007\/s40272-014-0076-2","type":"journal-article","created":{"date-parts":[[2014,6,4]],"date-time":"2014-06-04T22:41:56Z","timestamp":1401921716000},"page":"309-319","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":51,"title":["Comparison Between Paediatric and Adult Suspected Adverse Drug Reactions Reported to the European Medicines Agency: Implications for Pharmacovigilance"],"prefix":"10.1007","volume":"16","author":[{"given":"Kevin V.","family":"Blake","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cosimo","family":"Zaccaria","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francois","family":"Domergue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edith","family":"La Mache","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agnes","family":"Saint-Raymond","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Hidalgo-Simon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2014,6,5]]},"reference":[{"issue":"10","key":"76_CR1","doi-asserted-by":"publisher","first-page":"S19","DOI":"10.1016\/j.earlhumdev.2009.08.006","volume":"85","author":"I Choonara","year":"2009","unstructured":"Choonara I. Ethical and safety aspects of clinical trials in neonates. Early Hum Dev. 2009;85(10):S19\u201320.","journal-title":"Early Hum Dev"},{"key":"76_CR2","doi-asserted-by":"publisher","first-page":"79","DOI":"10.1136\/bmj.320.7227.79","volume":"320","author":"S Conroy","year":"2000","unstructured":"Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, Knoeppel C, Seyberth H, Pandolfini C, Raffaelli MP, Rocchi F, Bonati M, Jong G, de Hoog M, Van den Anker J, On behalf of the European Network for Drug Investigation in Children. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ. 2000;320:79\u201382.","journal-title":"BMJ"},{"key":"76_CR3","unstructured":"European Union Directive 2010\/84\/EU. Pharmacovigilance. Official Journal of the European Union 31.12.2010. http:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF. Accessed 14 Apr 2014."},{"issue":"6","key":"76_CR4","doi-asserted-by":"publisher","first-page":"665","DOI":"10.1046\/j.1365-2125.2002.t01-3-01689.x","volume":"54","author":"B Horen","year":"2002","unstructured":"Horen B, Montastruc J-L, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol. 2002;54(6):665\u201370.","journal-title":"Br J Clin Pharmacol"},{"key":"76_CR5","unstructured":"European Parliament and Council of the European Union (27.12.2006, a) Regulation (EC) No 1901\/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768\/92, Directive 2001\/20\/EC, Directive 2001\/83\/EC and Regulation (EC) No 726\/2004. Official Journal of the European Union: L 378\/1. http:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2006:378:0001:0019:en:PDF. Accessed 14 Apr 2014."},{"key":"76_CR6","unstructured":"Guideline on good pharmacovigilance practices (GVP) Module V \u2013 Risk management systems. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2012\/06\/WC500129134.pdf. Accessed 14 Apr 2014."},{"key":"76_CR7","first-page":"554","volume":"92","author":"RH Meyboom","year":"1991","unstructured":"Meyboom RH. Adverse reactions to drugs in children, experiences with \u2018\u2018spontaneous monitoring\u2019\u2019 in the Netherlands. Bratisl Lek Listy. 1991;92:554\u20139.","journal-title":"Bratisl Lek Listy"},{"key":"76_CR8","doi-asserted-by":"publisher","first-page":"1076","DOI":"10.1016\/S0895-4356(00)00190-6","volume":"53","author":"FJ Morales-Olivas","year":"2000","unstructured":"Morales-Olivas FJ, Martinez-Mir I, Ferrer JM, Rubio E, Palop V. Adverse drug reactions in children reported by means of the yellow card in Spain. J Clin Epidemiol. 2000;53:1076\u201380.","journal-title":"J Clin Epidemiol"},{"issue":"493\u201399","key":"76_CR9","first-page":"14","volume":"14","author":"E Kimland","year":"2005","unstructured":"Kimland E, Rane A, Ufer M, Panagiotidis G. Paediatric adverse drug reactions reported in Sweden from 1987 to 2001. Pharm Drug Saf. 2005;14(493\u201399):14.","journal-title":"Pharm Drug Saf"},{"key":"76_CR10","doi-asserted-by":"publisher","first-page":"327","DOI":"10.2165\/11319100-000000000-00000","volume":"33","author":"L Aagaard","year":"2010","unstructured":"Aagaard L, Blicher Weber C, Holme Hansen E. Adverse drug reactions in the paediatric population in Denmark. Drug Saf. 2010;33:327\u201339.","journal-title":"Drug Saf"},{"key":"76_CR11","first-page":"e45","volume":"14","author":"BC Carleton","year":"2007","unstructured":"Carleton BC, Smith MA, Gelin MN, Heathcote SC. Paediatric adverse drug reaction reporting: understanding and future directions. Can J Clin Pharmacol. 2007;14:e45\u201357.","journal-title":"Can J Clin Pharmacol"},{"key":"76_CR12","doi-asserted-by":"publisher","first-page":"e53","DOI":"10.1542\/peds.110.5.e53","volume":"110","author":"TJ Moore","year":"2002","unstructured":"Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ. Reported adverse drug events in infants and children under 2\u00a0years of age. Pediatrics. 2002;110:e53.","journal-title":"Pediatrics"},{"key":"76_CR13","unstructured":"European Medicines Agency. EudraVigilance: pharmacovigilance in the European economic area [online]. http:\/\/eudravigilance.emea.europa.eu\/highres.htm. Accessed 14 Apr 2014."},{"key":"76_CR14","unstructured":"Guideline on good pharmacovigilance practices (GVP) Module VI\u2014Management and reporting of adverse reactions to medicinal products. Available from http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2012\/06\/WC500129135.pdf. Accessed 14 Apr 2014."},{"key":"76_CR15","unstructured":"The rules governing medicinal products in the European Union. Notice to applicants and regulatory guidelines for medicinal products for human use. Vol. 2 [online]. http:\/\/ec.europa.eu\/enterprise\/sectors\/pharmaceuticals\/documents\/eudralex\/vol-2\/index_en.htm. Accessed 14 Apr 2014."},{"key":"76_CR16","unstructured":"MedDRA Maintenance and Support Services Organization. Introductory Guide to MedDRA Version 14.0. Chantilly, Virginia. March, 2011. http:\/\/www.who.int\/medical_devices\/innovation\/MedDRAintroguide_version14_0_March2011.pdf. Accessed 14 Apr 2014."},{"key":"76_CR17","doi-asserted-by":"publisher","first-page":"287","DOI":"10.2307\/2982975","volume":"153","author":"JR Copas","year":"1990","unstructured":"Copas JR, Hilton FJ. Record linkage: statistical models for matching computer records. J Royal Stat Soc. 1990;153:287\u2013320.","journal-title":"J Royal Stat Soc"},{"key":"76_CR18","doi-asserted-by":"publisher","first-page":"305","DOI":"10.1007\/s10618-006-0052-8","volume":"14","author":"GN Noren","year":"2007","unstructured":"Noren GN, Orre R, Bate A, Edwards IR. Duplicate detection in adverse drug surveillance. Data Min Knowl Discov. 2007;14:305\u201328.","journal-title":"Data Min Knowl Discov"},{"key":"76_CR19","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Clinical Investigation of Medicinal Products in the Pediatric Population E11. Current Step 4 version dated 20 July 2000. http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E11\/Step4\/E11_Guideline.pdf. Accessed 14 Apr 2014."},{"issue":"5","key":"76_CR20","doi-asserted-by":"publisher","first-page":"415","DOI":"10.2165\/11587540-000000000-00000","volume":"34","author":"K Star","year":"2011","unstructured":"Star K, Noren GN, Nordin K, Edwards IR. Suspected drug reactions reported for children worldwide: an exploratory study using VigiBase. Drug Saf. 2011;34(5):415\u201328.","journal-title":"Drug Saf"},{"issue":"9","key":"76_CR21","doi-asserted-by":"publisher","first-page":"1185","DOI":"10.1016\/j.vaccine.2007.12.033","volume":"26","author":"M Letourneau","year":"2008","unstructured":"Letourneau M, Wells G, Walop W, Duclos P. Improving global monitoring of vaccine safety: a quantitative analysis of adverse event reports in the WHO Adverse Reactions Database. Vaccine. 2008;26(9):1185\u201394.","journal-title":"Vaccine"},{"key":"76_CR22","first-page":"p5","volume-title":"Neurology of the newborn","author":"JJ Volpe","year":"2008","unstructured":"Volpe JJ. Neurology of the newborn. 5th ed. Philadelphia: Elsevier Health Sciences; 2008. p. p5.","edition":"5"},{"key":"76_CR23","unstructured":"Benes F. The development of the pre-frontal cortex, the maturation of neurotransmitter systems and their interactions. In: Nelson CA, Lucian M, editors. Handbook of developmental cognitive neuroscience. MIT press; 2001."},{"key":"76_CR24","doi-asserted-by":"publisher","first-page":"295","DOI":"10.1007\/s11096-013-9874-9","volume":"36","author":"L Aagaard","year":"2014","unstructured":"Aagaard L, Holme Hansen E. Adverse drug reactions in children reported by European consumers from 2007 to 2011. Int J Clin Pharm. 2014;36:295\u2013302.","journal-title":"Int J Clin Pharm"},{"key":"76_CR25","doi-asserted-by":"publisher","first-page":"91","DOI":"10.1007\/s40264-013-0133-8","volume":"37","author":"K Star","year":"2014","unstructured":"Star K, Edwards IR. Pharmacovigilance for children\u2019s sake. Drug Saf. 2014;37:91\u20138.","journal-title":"Drug Saf"},{"key":"76_CR26","unstructured":"European Medicines Agency. Questions and answers on the paediatric use marketing authorisation (PUMA). EMA\/753370\/2011. London, UK. September 2011. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Other\/2011\/09\/WC500112071.pdf. Accessed 14 Apr 2014."},{"key":"76_CR27","unstructured":"European Medicines Agency. 5-year report to the European Commission EMA\/428172\/2012. London, U.K. July 2012. http:\/\/ec.europa.eu\/health\/files\/paediatrics\/2012-09_pediatric_report-annex1-2_en.pdf. Accessed 14 Apr 2014."},{"key":"76_CR28","unstructured":"European Medicines Agency. Note for guidance\u2014EudraVigilance Human\u2014Processing of safety messages and individual case safety reports (ICSRs). EMA\/H\/20665\/04\/Final Rev.2. London, UK. October 2010. Available at https:\/\/eudravigilance.ema.europa.eu\/human\/euPoliciesAndDocs03.asp. Accessed 25 May 2014."},{"key":"76_CR29","doi-asserted-by":"publisher","first-page":"75","DOI":"10.1007\/s40264-012-0014-6","volume":"36","author":"SN Pal","year":"2013","unstructured":"Pal SN, Duncombe C, Falzon D, Olsson S. WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems. Drug Saf. 2013;36:75\u201381.","journal-title":"Drug Saf"}],"container-title":["Pediatric Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40272-014-0076-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40272-014-0076-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40272-014-0076-2","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40272-014-0076-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,7,29]],"date-time":"2022-07-29T16:23:45Z","timestamp":1659111825000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40272-014-0076-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,6,5]]},"references-count":29,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2014,8]]}},"alternative-id":["76"],"URL":"https:\/\/doi.org\/10.1007\/s40272-014-0076-2","relation":{},"ISSN":["1174-5878","1179-2019"],"issn-type":[{"value":"1174-5878","type":"print"},{"value":"1179-2019","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,6,5]]},"assertion":[{"value":"5 June 2014","order":1,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This content has been made available to all.","name":"free","label":"Free to read"}]}}