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Report Adverse Drug Reaction

Report an Adverse Drug Reaction 

At Lundbeck, we acknowledge our responsibility to people who depend on our products and knowledge to manage their disease. Reporting of potential adverse drug reactions by healthcare professionals and patients is important in order for us to continuously evaluate the benefits and risks of our products and take proactive action as warranted.

When we receive a report of a potential adverse drug reaction, the report will be entered in the Lundbeck Safety Database and it will be evaluated by a team of medical doctors, nurses and pharmacists. In case of any ambiguity or missing information in the report, we are obliged to contact the reporter for additional information. If the report is received from a patient, we will ask for permission to contact the patient’s doctor to confirm the provided information and potentially also request additional relevant information in order for us to assess the case.

 

Adverse drug reaction reports will be reported as individual cases to worldwide Health Authorities, such as the U.S. Food and Drug Administration (FDA) and also included in cumulative reports according to national legislation and requirements. In addition, they will be included in the ongoing monitoring for new signals that will help us to identify potential new risks associated with our products. Patient information and other personal data reported to Lundbeck will be further processed in an anonymized manner according to current Data Protection laws.

 

If you experience a potential adverse drug reaction, please consult your doctor for advice.

Dial 911 if you are experiencing a medical emergency. 


If you wish to report an adverse drug reaction directly to Lundbeck, you may use the online report form.

Please note that that we may contact you to follow-up on the information provided.


If you prefer to report directly to the FDA, you can call

1-800-FDA-1088 or visit the link below.


If you are located outside of the United States, you can

contact your local Lundbeck affiliate for more information.

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