Drug safety

Pharmacovigilance is a science that comprises all activites related to the reporting, assessment, understanding, prevention and procedures regarding side effects of medications, as well as the latest findings about the harmful effects of medications.

A side effect is any harmful and undesired reaction to a drug. This includes the side effects that arise from the use of a medication within its approved conditions, side effects that appear during the use outside the approved conditions (including, but not limited to overdose, off-label use, misuse and medical errors) and the effects that result from professional exposure.

Serious side effect is any side effect that includes the following: death o fan individual, life threatening condition, need for a hospital admission or an extension of a pending in-hospital treatment, permanent or severe disability, innate anomaly and other medically relevant conditions.

Adverse event is any harmful and undesired occurence, symptom or a disease (including deviations in laboratory testing) which temporally correlates with the drug administration, but does not necessarily have causal relationship with the drug.

Any adverse event that occurred during the use of a medication for which Makpharm holds marketing approval can be reported to:

1. HALMED (link http://new.halmed.hr/Farmakovigilancija/Kako-prijaviti-nuspojavu/)

2. Qualified pharmacovigilance personnel (farmakovigilancija@makpharm.hr or telephone number +385 91 29 29 605)

3. Makpharm (info@makpharm.hr or telephone numbers: +385 1 4840 342; +385 91 29 29 605)