Report published on the uses of medicines for children in the European Union
NewsPaediatrics
A Report on the survey of all paediatric uses of medicinal products in Europe
products in Europe on the survey of all uses of medicines for children in Europe was published today. The report is a key deliverable of the European Paediatric Regulation (EC) No 1901/2006 which aims to improve the health of children in the European Union.
The survey's results show that the prescription of off-label medicines (medicines used outside their marketing authorisation) and unauthorised medicines to children is still widespread in Europe.
The therapeutic classes that are used most frequently off-label or without a marketing authorisation are:
- anti-arrhythmics;
- antihypertensives (renin-angiotensin inhibitors and beta-blockers);
- proton-pump inhibitors and H2-receptor antagonists;
- anti-asthmatics;
- antidepressants (mainly selective serotonin re-uptake inhibitors, serotonin-norepinephrine re-uptake inhibitors and tricyclic antidepressants);
- contraceptives (in adolescents);
- antibiotics (in very young children).
The results of the survey will support the work of the Paediatric Committee (PDCO) when it develops its next inventory of paediatric needs. This is a list which describes the different therapeutic areas where research into and development of medicines for children is especially needed. This applies to both old (off-patent) or new medicines (including authorised medicines and those under development).