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Pharmacovigilance, as defined by the World Health Organization (WHO), is “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.”

Adverse Drug Reaction

An adverse reaction is a response to a medicinal product which is noxious and unintended. This includes adverse reactions which arise from:

  •     the use of a medicinal product within the terms of the marketing authorization
  •     the use outside the terms of the marketing authorization, including overdose, off-label use, misuse, abuse and medication errors
  •     occupational exposure.




How to, and to whom, report an adverse reaction

Contact the Competent Authority’s Pharmacovigilance Office.

If you wish to directly notify Kedrion about a suspected adverse reaction related to our drugs, please fill in the form below:




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Patient Details (person who experienced the adverse event)

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Medicinal product details

Please specify the Kedrion product
Please specify the batch number
Please specify the adverse event description
Please specify if the patient received any treatment, or if he stopped taking the medicine.

Other questions

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In processing your personal data, Kedrion will fully comply with internationally recognized standards of data protection. In doing so, Kedrion ensures compliance of its staff with strict standards of security and confidentiality.

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