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 treatment ^{1 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 unintended ^{11 2} .
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 want to directly report an adverse event or reaction to Cosmo Technologies Ltd and Cassiopea S.p.A. occurred with a medicinal product for which they are the Marketing Authorization Holders³, including those associated or not to a special situation (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) please use the contact options below:

Phone number and/or email address:

1. Guideline on good pharmacovigilance practices (GVP) – Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2)
2. E 2 D Post Approval Safety Data Management
3. Direttiva 2001/83/Ce Del Parlamento Europeo E Del Consiglio

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