Throughout the lifecycle of a medicinal product, from clinical trials to post-marketing surveillance, our goal is to ensure patient safety.

All medicinal products have benefits and risks and it’s expected that the benefits outweigh any associated risks of harmful reactions. All medicines can cause reactions; however, most people take medicines without suffering any serious side effects. In order to safeguard patients, Zambon UK collects safety information to monitor the benefit-risk profile of our products to identify potential changes at an early stage. When a new product is first marketed, its efficacy has been well defined. However, since a relatively small number of patients who fit particular inclusion and exclusion criteria will have taken part in clinical trials during the development of a new medicine, it is likely that only the more common adverse drug reactions may have been identified. It is only after larger scale use of the product in real-world clinical practice that less common adverse drug reactions including drug interactions may be detected and an indication of the frequency of the more common adverse drug reactions determined. 

Ensuring patient safety is extremely important to Zambon UK. We have legal and ethical responsibilities to collect, analyse and report side effects.  We strongly encourage healthcare professionals and patients to report side effects experienced whilst taking our products.

Pharmacovigilance Organisation at Zambon

Zambon has implemented a global pharmacovigilance system with a dedicated team of scientists and doctors. Zambon has established:

• A Central Pharmacovigilance Unit located in Bresso (Italy), which collects and analyzes drug safety information reported worldwide, in order to continuously update and re-evaluate the risk-benefit profile of Zambon products and confirm their therapeutic effects.
• Local Pharmacovigilance Operational Units present in each Zambon affiliate, which collect, record,  and communicate the safety information reported by patients, investigators and healthcare professionals in the course of their clinical practice. These units also interface with national health authorities.

Find out how to report side effects at the link here.