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If you would like to report any side affects you or someone you care for may be experiencing or have any questions about a pharmaceutical or medical product please contact:
- If you are located in the United States: MedWatch – the Food and Drug Administration’s Safety Information and Adverse Event Reporting Program at 1-800-332-1088 or access online reporting at https://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm
- If you are located in the EU: Please visit https://www.adrreports.eu/EN/national.html to locate the appropriate national medicines regulatory authorities in the EEA for information on how to report a side effect.
You are further instructed to refrain from discussing within the community any ongoing litigation, including, but not limited to, litigation concerning pharmaceuticals or medical devices.
You further understand that you should refrain from making any comments or references to “off-label” uses (uses which are not within the FDA-approved indications or labeled conditions of use of any medical product or are considered pre approval promotion in nature).
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