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Keywords:

  • children;
  • Europe;
  • licensing;
  • off-label medicines;
  • survey

Aims To evaluate the activity of the European Medicines Evaluation Agency with regard to the registration for paediatric use of new medicines granted a marketing authorization.

Methods European Public Assessment Reports published on the Internet from January 95 until April 98 have been analysed using the browser Microsoft Explorer and the software Adobe Acrobat Reader.

Results Of the 45 new substances licensed since January 95, 29 (64%) were of possible use in children but only 10 were licensed for paediatric use. For the 19 drugs of possible use in children, but not approved for such a use, in nine instances (47%) their summary of product characteristics reported that their use in children has not been established.

Conclusions A change of practice by pharmaceutical companies and regulatory authorities is imperative so that children are not precluded from having the same rights to medicines as adults.