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 Protection (GDPR)

The data controller is NuKlover Sp. z o.o., headquartered at ul. Franciszka Klimczaka 1, 02-797 Warsaw, Poland.

Your personal data will be processed solely for the purpose of fulfilling pharmacovigilance obligations, in accordance with:

the Personal Data Protection Act of 10 May 2018 (Journal of Laws 2018, item 1000), and
the Pharmaceutical Law of 6 September 2001 (consolidated text: Journal of Laws 2017, item 2211, as amended).

For healthcare professionals – reporting is mandatory by law.
For all other individuals – reporting is voluntary, but necessary for the report to be accepted.

Every individual has the right to access and correct their personal data.