Pharmacovigilance

What is Pharmacovigilance?

Pharmacovigilance is defined as the science and activities for detecting, assessing, understanding and preventing adverse events or any other drug-related problems.

What is an Adverse Drug Reaction (ADR)?

An adverse drug reaction is defined as a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function, where there is a reasonable possibility of a causal relationship.

Note: an ADR is different from an Adverse Event (AE), which is any untoward medical occurrence in a patient exposed to a health product and which does not necessarily have a causal relationship with the health product.

How to report Adverse Drug Reactions?

Select the country where the event occurred to view the responsible pharmacovigilance contact and report an ADR.

Privacy Policy

Personal information collected through Adverse Drug Reaction reporting will be used for regulatory reporting purposes only. For more information, please see our Privacy Policy.

Frequently Asked Questions (FAQ)

Who can report an Adverse Drug Reaction (ADR)?

We accept ADR reports from healthcare professionals responsible for treatment and care, and hospital administrators involved in the reporting of ADRs.

What if I am not sure that the product caused the ADR? Do I still report it?

Yes - if you suspect that an ADR may be causally related to BLES^®, it should be reported.

What happens after I submit an ADR report?

Our pharmacovigilance team reviews and evaluates every report received. If necessary, the reporter will be contacted for additional information to conduct a thorough investigation. If the ADR is considered serious, it will be reported to the appropriate regulatory authority in compliance with applicable regulations.

Will my identity be made public if I report an ADR?

No - patient and reporter identities are handled with strict confidentiality. If applicable, your name and contact information will be shared with the regulatory authorities in accordance with the requirements for reporting of ADRs.