Reporting suspected adverse events

This guidance explains how to send GALVANTA COMPANY LIMITED information about an unwanted medical occurrence involving an item bearing, or represented as connected with, its name.

Effective: 23 September 2026. Last reviewed: 23 September 2026.

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Urgent medical help

For urgent medical assistance, seek emergency medical care or consult a qualified healthcare professional. Do not wait for a company reply.

This reporting route does not provide clinical assessment or emergency care. No response time is promised through this website.

What may be reported

A suspected adverse event is an unwanted medical occurrence after use of a medicine, whether or not the medicine caused it.

Reports may also concern a medication error, unexpected exposure, a device problem associated with a medical occurrence, or another circumstance relevant to a suspected safety concern.

You do not need to establish causation before reporting. Describe what is known and distinguish it from assumptions.

Current company status

The company’s current pharmaceutical status is set out in Regulatory information.

Providing a report does not establish that the item was manufactured or supplied by the company. A concern may nevertheless be relevant where the item or communication uses the company’s name.

Reporting route

Email [email protected] with the subject “Safety report”, or select Safety / product quality on the Contact page.

All published enquiry subjects reach the same mailbox. It is not a separate emergency or clinical service.

Information to include

Provide, where known:

  • the medicine or material name and presentation;
  • batch or lot information;
  • a description of the occurrence and relevant dates;
  • whether urgent care has been sought;
  • enough non-identifying information to distinguish the person concerned;
  • your role and a contact for clarification.

Report even if some details are not yet known. A reporter may be a patient, relative, healthcare professional or another person with relevant information.

Personal information

Send only information necessary to describe the concern. Avoid full patient names, addresses, complete medical records, identity documents and unrelated health history in an initial message.

Additional information may be needed for a lawful assessment or authority report. Arrange an appropriate exchange before sending sensitive records.

The Privacy notice explains the common mailbox, service providers and retention rules. The website does not promise confidential clinical handling or an independent reporting channel.

Quality and authenticity concerns

A suspected packaging defect, contamination, incorrect label or other product-quality problem may be reported under the Product-quality notice.

For suspected falsification or misuse of the company’s identity, read the Authenticity notice. One concern may fall within more than one category.

Authorities and follow-up

A report can also be made directly to the competent health authority. Reporting through this website does not replace a professional’s statutory duty or another required reporting route.

Causation, authenticity and responsibility require separate assessment of the evidence. No investigation outcome is promised by submission.

Changes

This guidance may change with the company’s regulatory status or reporting arrangements. The stated effective date identifies its version.