Reporting of Adverse Drug Reactions

  • What is an Adverse Drug Reaction?
  • Why you should report Adverse Drug Reaction?
  • How to report Adverse Drug Reaction?
What is an Adverse Drug Reaction?

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.

Why you should report Adverse Drug Reaction?

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.

How to report Adverse Drug Reaction?

You can report an adverse drug reaction via email address:

When reporting please provide the following information if possible:

  • Patient details
  • Patient initials
  • Female or male?
  • Age

Reporter details

  • Name
  • Contact details

Product details

  • Name of product?
  • What was the product taken for?
  • How do you take the product (dose, how often)?
  • Description of adverse reaction
  • Date of the onset of the adverse reaction
  • What happened?
  • Did you receive treatment for the adverse reaction?
  • Have you recovered?


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