Report an adverse event

Reporting suspected adverse drug reactions or medical device adverse incidents

Adverse events should be reported. Both health professionals and patients can submit information through the Yellow Card Scheme website in the UK or the HPRA website in the Republic of Ireland.

United Kingdom

The Yellow Card Scheme is run by the Medicines and Healthcare products Regulatory Agency (MHRA).

The scheme is used to collect information from health professionals and patients on suspected adverse drug reactions or medical device adverse incidents. The continued success of the Yellow Card Scheme depends on your willingness to report suspected adverse drug reactions and medical device adverse incidents.

Reporting forms and information can be found at https://yellowcard.mhra.gov.uk

Republic of Ireland

Healthcare professionals and patients can report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2;

Tel: +353 1 6764971; Website: https://www.hpra.ie/report-an-issue/medicines-for-human-use/side-effects

How to report a possible side effect?

If you have experienced an adverse event or have prescribed a medicine and become aware of an adverse event please report this to

medinfo@norgine.com

To help us process your information quickly and effectively, please remember to report as much relevant information as possible. At a minimum you will need to provide the following:

The name of the Norgine product involved;
A description of the possible side effect itself, such as the signs and symptoms experienced, date the possible side effect started and the result of the possible side effect.
Details of the person who experienced the possible side effect. e.g. initials and/or other identifiers, such as gender, date of birth;
The contact information of the person who is reporting the issue and country where it is reported from;

You can also report an adverse reaction to your local healthcare regulatory agency through the country specific available means (e.g., yellow card system)

If you experience a side effect that causes you concern, please tell your healthcare professional immediately.

Medical Information Enquiry

For medical information enquiries regarding Norgine products, please contact:

medinfo@norgine.com

For Patients: Please note that Norgine is unable to provide individual treatment advice. Please consult your doctor or pharmacist who are in the best position to advise you about your medicine or treatment.

Product Quality Complaint

To report a new product quality complaint regarding a Norgine product, please email:

medinfo@norgine.com

Data Privacy statement:

Norgine will store the personal data you provide for the purposes of handling the adverse event, medical enquiry or product quality complaint reported. Your personal data will only be shared with the relevant departments of the Norgine Group, our trusted specialised partners and healthcare authorities if needed. Data will be retained for a period in line with both our industry obligations as well as applicable data protection laws. To find out more about your privacy rights and how we process and keep your personal data secure, please refer to our Privacy Policy at https://www.norgine.co.uk/privacy-policy/.

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