Discrepancies Between the Labels of Originator and Generic Pharmaceutical Products: Implications for Patient Safety

Author:

Thoenes Alexandra,Cariolato Luca,Spierings Julian,Pinçon Alexis

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical)

Reference17 articles.

1. Duke J, Friedlin J, Ryan P. A quantitative analysis of adverse events and “overwarning” in drug labeling. Arch Int Med. 2011;171:941–54.

2. European Medicines Agency. Scientific guidelines with SmPC recommendations, rev 4, 25 January 2017. London: EMA; 2017.

3. King JP, Davis TC, Bailey SC, Jacobson KL, Hedlund LA, Di Francesco L, Parker RM, Wolf MS. Developing consumer-centered, nonprescription drug labeling. Am J Prev Med. 2016;40:593–8.

4. Kircik L, Sung JC, Stein-Gold L, Goldenberg G. United States Food and Drug Administration product label changes. J Clin Aesthet Dermatol. 2016;9:39.

5. Marcussen M. Branded versus generic label alignment: assessing safety and compliance in the US. PharmacoVigilance Rev 2016;9(1):6–10.

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