Abstract
This chapter describes the definitions of adverse reactions/events, pharmacovigilance systems, their limitations and basic problems, as well as adverse events connected with radiopharmaceutical agents.
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Notes
- 1.
In European law instead of ‘drug’, the term ‘medicinal product’ is used.
- 2.
In the USA, the term ‘drug approval’ is used; in Europe the term ‘marketing authorisation’.
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Fischer, M., Brinker, A., Sickmüller, B. (2015). Safety of Medicines: Detection and Reporting Adverse Reactions. In: Kampen, W., Fischer, M. (eds) Local Treatment of Inflammatory Joint Diseases. Springer, Cham. https://doi.org/10.1007/978-3-319-16949-1_1
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