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. 1999 Jul;48(1):15-8.
doi: 10.1046/j.1365-2125.1999.00981.x.

Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use

P Impicciatore  1 , I Choonara
Affiliations

Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use

P Impicciatore et al. Br J Clin Pharmacol. 1999 Jul.

Abstract

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.

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