The word Pharmacovigilance originated from two Latin words, meaning of medicine (=farmakon) continuous watch (=vigilare).
Pharmacovigilance includes activities which ensure the safe use of the registered product during the whole lifetime of drug by collecting more information on how to use it more and more safety.
Set of activities aimed at identifying, assessing, understanding and preventing adverse effects or any other problem related to the use of medicines, in order to ensure a favorable benefit/risk ratio for the population.
The manufacturer collects the possible side effects of goods from reports and after evaluation of these adverse events - in case of need - dispatch, track, revise the risk profile based on new data compared to benefit. The patient leaflet and on usage can be modified according to data results.
The correct administration and use of medicine by both patients and health care professional is important for IBSA.
You can report adverse event to the Marketing Authorisation Holder, by click on CONTACT . Your data is used only perform the Pharmacovigilance activity (further Privacy/Data protection). OR adverse event can be reported to www.ogyei.gov.hu. drug adverse event site.