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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 http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm
- If you are located in the EU: Please visit http://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.
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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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