Pharmacovigilance

“Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem”

World Health Organization (WHO)

What is an adverse event?

Adverse event is any untoward medical occurrence in a patient to whom a medicinal product is administered, and which does not necessarily have a causal relationship with this treatment1¹, ². An adverse event can therefore be any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.

What is an adverse reaction?

Adverse reaction is a response to a medicinal product which is noxious and unintended³ .An adverse reaction, in contrast to an adverse event, is characterized by the fact that a causal relationship between a medicinal product and an occurrence is suspected.

What to do in a case of suspected Adverse Drug Reaction/Adverse Event?

If you experience an adverse event or adverse reaction during or following pharmacological treatment, please consult your doctor before taking any clinical action, then report it immediately to your health authority, or the pharmaceutical company, or the health care professional or pharmacist.

Your feedback is invaluable for improving our medications and ensuring their safe use.

If you wish to notify directly to Cosmo for any our medicinal product about an adverse reaction and associated or not to a special situation (e.g. Off-label use, Overdose, Misuse, Abuse, Medication error, Occupational or accidental exposure, lack of efficacy, unexpected benefit, exposure during lactation, during pregnancy or at the time of conception, suspected transmission of an infectious agent due to medicinal product) rather than for any product quality complaints choose the following contact channels:

1. see GVP Annex IV ↩︎
2. based on ICH-E2D Guideline ↩︎
3. DIR 2001/83/EC Art 1(11) ↩︎