Any harmful and unintended reaction to a medicine occurring during the administration of the normal dose of a medicine to human subjects (for treatment, disease prevention, diagnosis, rehabilitation, improvement or alternation of the physiological function), or during the administration of any dose of a medicine in a clinical trial.
Adverse reaction reporting to the drug for which Zdravlje is a marketing authorization holder leads to new insights about its safety profile, and for our company patient safety is of paramount importance.
It is our ethical and regulatory responsibility to monitor the safety of the medicines throughout their marketed life – known as pharmacovigilance.
Timely reporting to Regulatory Bodies is critical to enable compliance with regulatory requirements.
You can report an adverse drug reaction via email address: farmakovigilanca@zdravlje.co.rs
When reporting please provide the following information if possible:
Reporter details
Product details