ArticleBMJ paediatrics open2020
Does the EU's Paediatric Regulation work for new medicines for children in Denmark, Finland, Norway and Sweden? A cross-sectional study.
Article in BMJ paediatrics open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed.
- Off-Label Manipulation of Paediatric Medication Remains a Challenge in Clinical Practice: An Observational Study.Acta paediatrica (Oslo, Norway : 1992) · 2026Observational
- Access to child-appropriate medicines: an exploratory survey of the use of paediatric use marketing authorisation products in the UK.European journal of pediatrics · 2025Article
- Paediatric formulations-part of the repurposing concept?Frontiers in medicine · 2024Article
- Medication errors related to high-alert medications in a paediatric university hospital - a cross-sectional study analysing error reporting system data.BMC pediatrics · 2023Article
- Utilisation of drugs for the treatment of psychiatric diseases in the pediatric population: focus on off-label use.Frontiers in pharmacology · 2023Article
- Manipulated Oral and Rectal Drugs in a Paediatric Swedish University Hospital, a Registry-Based Study Comparing Two Study-Years, Ten Years Apart.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project.British journal of clinical pharmacology · 2022Review
- Development and evaluation of an assessment of the age-appropriateness/inappropriateness of formulations used in children.International journal of clinical pharmacy · 2022Article
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Authors and funding
6 authors.
Funding
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Abstract
objectiveThe aim of this study was to assess the marketing status of the new paediatric medicinal products listed in the 10-year report as initially authorised between 2007 and 2016, reflecting the product availability in four Nordic countries.
designThis is a cross-sectional study.
settingAnalysis of the national medicine agency's databases in Denmark, Finland, Norway and Sweden. DATA SOURCE: New medicinal products with paediatric indications and new paediatric formulations listed in the Annex of European Medicines Agency's EU Paediatric Regulation 10-year report. DATA ANALYSIS: The products were classified according to national marketing status between January 2019 and March 2019, whether a product was authorised and whether the product was marketed.
main outcome measuresThe percentages of the new medicinal products with paediatric indications and new paediatric formulations having a valid marketing authorisation and being marketed, both in terms of the sums of all countries and separately for each country.
resultsAcross the four countries, 21%-32% (16/76-24/76) of the new medicinal products were not marketed. Of the new formulations relevant to children, 29%-50% (16/56-28/56) were not marketed, and a significant proportion of these products had never been marketed.
conclusionsThis study reflects the reality of the implementation of the Paediatric Regulation. The results show that several new paediatric medicines and new formulations are not marketed. This affects the product availability. Similar data from other countries are needed to evaluate the overall European status to find remedies to current situation and increase the availability of the medicines for children.
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