Report a Suspected Adverse Event

If you need to report a suspected adverse event or side effect relating to a medicinal product, our Pharmacovigilance (PV) Reporting Tool will help identify the appropriate reporting route.

Komtur provides pharmacovigilance services on behalf of Marketing Authorisation Holders (MAHs) for selected medicinal products in specific countries. Where we are responsible for pharmacovigilance activities, our qualified team will guide you through the reporting process in accordance with applicable regulatory requirements.

If Komtur is not responsible for the product in your selected country, we will direct you to the appropriate reporting route.

Find the correct reporting route

Important Information

This tool is intended to identify the appropriate reporting route for suspected adverse events relating to human medicines.
We do not collect or store patient information through this webpage.
Reporting responsibilities vary by product and country and may change over time.
This tool does not provide medical advice. If you require medical attention, please contact your doctor, pharmacist or other healthcare professional immediately.

Please select your role*

First Name*

Last Name*

E-Mail*

Im a*

Im located in*

Product or Active Substance*

Please enter the exact name of the Product or Active Substance.

Marketing Authorisation Holder*

Please enter the exact name of the Marketing Authorisation Holder. You can find this information in section 6 of the leaflet.

By submitting this form, you agree to be contacted by Komtur only if your case is in scope. If your report concerns a veterinary product, please use your local authority’s reporting route; Komtur will not receive your submission.Your personal data will only be processed and retained as necessary to manage this adverse event in line with our legal obligations and our contractual obligations with the Marketing Authorisation Holder (MAH) and/or the relevant authority.*

no forms for downoad - these depend on result

If a match is found Komtur is the designated pharmacovigilance contact

Komtur provides pharmacovigilance services for this medicinal product in the selected country.

Please contact our Pharmacovigilance team using one of the methods below. A qualified member of our team will guide you through the reporting process and any information required to fulfil applicable regulatory obligations.

Telephone

If no match is found No Komtur reporting route was found

We could not identify a Komtur pharmacovigilance reporting route for the product and country entered.

Please verify the product name and try again.

If the result remains unchanged, please follow the reporting instructions provided in the Package Leaflet or contact the Marketing Authorisation Holder, the pharmacy that supplied your medicine or the relevant national medicines authority.

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