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<p>There are various sources of information and data bases that provide information on medicines in Germany and the European Union. The summary of product characteristics (SmPC) summarizes the licensing status and main properties of a&#xa0;medicinal product. Pediatric investigation plans provide information about the agreed pediatric drug development program. Information on suspected adverse events is available in a&#xa0;European database. Further information, also on drugs that are currently not licensed for the pediatric population, can be found in the “Kinderformularium”.</p>

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Arzneimittel: zugelassen oder nicht?

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年7月8日

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  • Sabine Scherer,
  • Bernhard Erdlenbruch

摘要

There are various sources of information and data bases that provide information on medicines in Germany and the European Union. The summary of product characteristics (SmPC) summarizes the licensing status and main properties of a medicinal product. Pediatric investigation plans provide information about the agreed pediatric drug development program. Information on suspected adverse events is available in a European database. Further information, also on drugs that are currently not licensed for the pediatric population, can be found in the “Kinderformularium”.