Pharmacovigilance

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According to the World Health Organization, pharmacovigilance encompasses the sciences and activities related to detecting, assessing, understanding, and preventing adverse effects and any other medicine-related problems.

Adverse drug reaction: What is an adverse event?

An adverse reaction is understood as a harmful and unintended response to a medicinal product used under therapeutic conditions. This includes reactions arising from use within the marketing authorization, from use outside approved labeling (overdose, off-label use, medication errors), and from occupational exposure.

How and to whom to report an adverse reaction

If you wish to report a suspected adverse reaction related to our plasma-derived therapies, please complete the pharmacovigilance form available on this website or contact our clinical team directly. Your report - together with clinical and treatment details - enables us to investigate, implement safety measures, and provide follow-up. We ensure confidentiality of the information and maintain contact for subsequent clinical monitoring.

Why is Hemova interested in adverse events?

Although Hemova's products are rigorously evaluated in clinical studies before approval and commercialization, not all adverse events may be identified during these early stages. For this reason, any information related to the use of our medicines is of great importance to the company.

Data collected globally are continuously analyzed and monitored by Hemova, together with health authorities, with the aim of promptly detecting new effects and communicating relevant information to patients and healthcare professionals.

Pharmacovigilance and Adverse Events Form

Or email Hemova directly:

Contact email: info@hemova.com.co