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2. European Medicines Agency. Medicines Under Additional Monitoring. Available from: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medicines-under-additional-monitoring. Accessed February 20, 2024.
3. Australian Government. Therapeutic Goods Administration. The Black Triangle scheme. Available from: https://www.tga.gov.au/how-we-regulate/monitoring-safety-and-shortages/report-adverse-event-or-incident/report-adverse-events-medicines-and-biologicals/black-triangle-scheme#:~:text=How%20the%20Black%20Triangle%20Scheme,Product%20Information%20(PI)%20documents. Accessed February 20, 2024.
4. UK Government. The Black Triangle Scheme. Available from: https://www.gov.uk/drug-safety-update/the-black-triangle-scheme-or#:~:text=A%20Black%20Triangle%20symbol%20is,a%20new%20route%20of%20administration. Accessed February 20, 2024.
5. European Medicines Agency. Guideline on Good Pharmacovigilance Practices Module X—Additional Monitoring; 2013. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-x-additional-monitoring_en.pdf. Accessed February 20, 2024.