Pharmacovigilance covers the activities related to the detection, assessment, understanding and prevention of adverse events or any other problem related to medicines and medical devices.

What is a suspected adverse drug reaction?

Any unwanted clinical or laboratory manifestation that occurs after the administration of one or more medicines.

What is a suspected adverse medical device incident?

Any verified event related to the use of a medical device caused by a malfunction or deterioration of the device.

What should I report?

Any discomfort or problem (suspected adverse reaction or adverse incident) related to the use of medicines or a medical device.

What information do I need to report?

• Name and phone or email of the reporter

• Patient data (initials, gender and age)

• Name of the medicine or medical device (and, if possible, lot number)

• Discomfort experienced