REPORTING OF ADVERSE EVENTS
What is an adverse reaction?
An adverse reaction to a medicinal product is any harmful and unintended effect associated with its use, regardless of whether it was anticipated in the product’s registration documentation.
Why should adverse reactions be reported?
By reporting adverse reactions, you help us enhance the safety of medicinal products. Your report enables NuKlover to fulfill its legal obligations to the relevant public health authorities.
The information collected is also used to update the product’s Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) — even if the causal relationship between the product and the reaction has not yet been confirmed.
How to report an adverse reaction?
Please contact our Pharmacovigilance Department:
E-mail: pv@nuklover.com
Phone 24/7: +48 888 575 473
More information and adverse reaction reporting forms are available at the website of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
https://www.urpl.gov.pl
Personal Data Processing and Protection Policy
This Personal Data Processing and Protection Policy sets out the principles for the processing and protection of personal data by NUKLOVER Sp. z o.o., with its registered office in Warsaw, at F. Klimczaka 1, 02-797 Warsaw.
Personal Data Processing and Protection Policy