Adverse Event and/or Product Complaint Form

An Adverse Event (AE) is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Product Complaint (PC) is defined as any apparent changes in the physical or chemical properties (e.g., appearance) or dissatisfaction with the quality of a product, including but not limited to product effectiveness, product integrity, labeling, packaging, shortages and mix-ups.

Reporter Information:

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