1. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP), Module V—risk management systems (Rev 2); 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf
. Accessed 13 March 2018.
2. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP), Module XVI—risk minimisation measures: selection of tools and effectiveness indicators (Rev 2); 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/02/WC500162051.pdf
. Accessed 13 March 2018.
3. Rubino A, Artime E. A descriptive review of additional risk minimisation measures applied to EU centrally authorised medicines 2006–2015. Expert Opin Drug Saf. 2017;16:877–84.
4. European Medicines Agency. Mycamine: EPAR product information; 2011.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000734/human_med_000911.jsp&mid=WC0b01ac058001d124
. Accessed 13 March 2018.
5. US Food and Drug Administration. Vfend summary of product characteristics; 2008.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s023,021267s024,021630s013lbl.pdf
. Accessed 13 March 2018.