Pharmacovigilance

Chiesi has a system for pharmacovigilance for medicines that are marketed or under clinical development. We take action where necessary to ensure that the safety of our medicines is continuously evaluated and understood.

What is Pharmacovigilance?

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.⁽¹⁾

Pharmacovigilance is an activity contributing to the protection of patients and public health.

What is an Adverse Drug Reaction?

An adverse drug reaction is a response to a medicine product which is harmful and unintended.

Adverse reactions may arise from use of the medicine within or outside the terms of the marketing authorisation or from occupational exposure. Conditions of use outside the marketing authorisation include off-label use, overdose, misuse, abuse and medication errors.

UK

Adverse events should be reported via MHRA Yellow Card.

Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adverse events should also be reported to :

Chiesi Limited on 0800 0092329 (UK) or PV.UK@Chiesi.com.

IRELAND

Adverse events should be reported to HPRA Pharmacovigilance - www.hpra.ie.

Adverse events should also be reported to :

Chiesi Limited on 1800 817459 (IE) or PV.UK@Chiesi.com.

References

1. The importance of pharmacovigilance: safety monitoring of medicinal products. World Health Organization, WHO. 2002. Available at: https://www.who.int/publications/i/item/10665-42493

UK-CHI-2500066 | January 2025