Pharmacovigilance is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”.
Reporting Suspected Adverse Reactions
Most of us will not experience any problems when using medicines. However, all medicines
have some risks associated with their use and so a small number of people may experience an
adverse reaction (also known as a side effect).
What is an adverse reaction (side effect)?
An adverse reaction is formally defined as a “response to a medicinal product which is noxious
and unintended”. This definition includes any harm associated with the use of a medicine
including use following overdose, misuse or error.
What should I do if I think I may have experienced an adverse reaction (side
effect)?
If you are concerned that you have had a suspected adverse reaction to a medicine, you may need to contact your healthcare professional who can advise on any treatment that may be needed. They can also report the issue to EIPICo on your behalf.
If you wish to directly report an adverse reaction you can use the EIPICo’s online reporting service. This includes patients, caregivers, other members of the public and healthcare professionals.
Why is it important for me to report suspected adverse reactions?
Monitoring the quality, efficacy and safety of our products throughout their life cycle, from
clinical development to prescription and consumption, is a priority to protect patient safety.
Some rare or late onset adverse events are often only detected at this time. In order to maximize
our knowledge on the use of our portfolio in real-world conditions, EIPICo.'s
Pharmacovigilance department has established an effective organization to passively and
actively collect pharmacovigilance data from all sources of information around the world.
Report an Adverse Event
The patients’ role in reporting adverse drug reactions is a key element in building an improved system of pharmacovigilance which monitors the benefit and risk profiles of our pharmaceutical products.Click here
Request Medical Resources
If you have a general question about EIPICO medicinesClick here