Pharmaco-vigilance and Vigilance

Committed to Patient Safety
At Dompé we are committed to ensuring the safety of our products for the patients we serve. We know that adverse events can happen, and it's not always possible to predict who will get them. It is vital for us to continuously monitor the safety of our products. Through hearing about your experiences using a Dompé product and others like you we are able to offer the best possible information to patients, and healthcare providers.

What is an Adverse Drug Experience?

Title 21 of the Code of Federal Regulations (CFR) 314.80, defines an Adverse Drug Experience (ADE) as: Any undesirable event that is associated with the use of a drug in humans, whether or not considered drug-related.

This may also include:

  • Events occurring in the course of the use of a drug product in professional practice

  • Drug overdose

  • Drug abuse

  • Drug withdrawal

  • Any failure of expected pharmacologic action.

As a pharmaceutical company, Dompé collects safety information arising from the use of its medicinal products pertaining to special conditions, even in the absence of an adverse event, such as:

  • Misuse,

  • Off-label use,

  • Medication error or any problem related to the use of the product,

  • Exposure during pregnancy or during breastfeeding,

  • Suspected transmission of an infectious agent via medicinal product,

  • Falsified medicinal product.

Dompé Pharmacovigilance Department will notify the Regulatory Authorities about any ADE in line with applicable law requirements.

What is an adverse event to a medical device?

An adverse event can refer to any unfavorable occurrence involving a medical device in the market.

Contact Dompé

You may write to Dompé Pharmacovigilance department filling in the form.

Outside the United States

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What to do in case of observed or suspected adverse events for human medical products

Suspected adverse events and serious problems can be reported to FDA at 1-800-FDA (332)-1088