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Throughout Europe, between 11% and 80% of drugs prescribed for children are either not specifically licensed for human use (unlicensed) or are prescribed outside the terms of their product licence in relation to dosage, age, indication and route of administration (off-label, OL) both in the hospital and community settings.1
Some steps to try to solve the problem of OL have recently been taken. In December 2006, new European legislation was approved, the aim of which is to ensure that drugs used by children are subject to high-quality research by giving financial incentives to the drug industry.2 Another important step is the recognition of …
Competing interests: None.
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