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Report an adverse drug reaction

Report a side effect or other safety information

Please note that you should consult your general practitioner or other qualified health care provider if you:

 

  • Experience a health problem
  • Have questions regarding your personal health
  • You (or the person concerned if you are reporting on someone else’s behalf) are experiencing side effect(s) related to the use of a medicinal product  

If you are participating in a clinical trial, please report the side effect to your study site.

 

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 consent is provided. 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 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.

To learn more about how Lundbeck processes your personal data when you report a side effect, visit the menu “Your privacy” below or click here.

If you wish to report an adverse drug reaction directly to Lundbeck, you may use the online contact form or call 1-866-880-4636.

If you've provided consent, please note that we may contact you to follow-up on the information provided..

If you prefer to contact a Lundbeck representative in your own country, you can look up the relevant contact information here.

Further information

The following situations constitute examples of safety information which are important to the ongoing safety monitoring of Lundbeck medications:

 

  • Suspected side effects
  • Pregnancy while taking Lundbeck medication (this also applies for pregnancies without any associated complications and if the father was the person treated with Lundbeck medication)
  • Suspected side effects in nursing children if the mother is treated with Lundbeck medication
  • Overdoses, misuse, or abuse of Lundbeck medication
  • Lack of efficacy
  • Medication errors or intentional deviations from the intended treatment schedule or method

In the side effect reporting form, you will be provided with the opportunity to fill in information on who is reporting the side effect, the patient and type of Lundbeck medication involved, as well as details on the side effect. Information on other medical conditions and/or additional medications taken can also be provided.

 

Please do not provide personal information such as full name, address or social security/personal identity number when filling out the form. 

Any information shared with Lundbeck will be treated confidentially in line with Lundbeck’s data handling procedures and in accordance with current data protection legislation. Data reported on side effects will be entered into the Lundbeck global safety database and retained for the time frame required by current legislation. Lundbeck is obligated by law to report information on side effects to Health Authorities.

 

To find out more about how we process personal data and what your rights are please visit Privacy Notification or contact the Lundbeck Data Protection Officer at dataprivacy@lundbeck.com.

Questions about Lundbeck products: info@lundbeck.com

Questions about reporting side effects: safety@lundbeck.com

Questions about the reporting form: info@lundbeck.com

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