Disclaimer

Each time you search for a web report you will be shown a disclaimer. To view individual reports you must confirm that you have read and understood the disclaimer.

The disclaimer contains the following information:

  • The information on this website does not reflect any confirmation of a potential link between the medicine and the observed effect(s).
  • The information on this website concerns suspected associations that reflect the reporter's observations and opinions. A scientific assessment of a cause-and-effect relationship between a medicine and an effect is part of the continuous monitoring of the benefits and risks of a medicine; the assessment takes into account many other factors, such as the medical condition and the medical history of the patient.
  • The information may include known side effects already listed in the summary of product characteristics (SmPC) and the package leaflet.
  • The number of suspected side effects in EudraVigilance should not serve as a basis for determining the likelihood of a side effect occurring. This is because the numbers need to be put into context with other factors, such as how many people take the medicine and how long the medicine has been on the market.
  • Each individual case in EudraVigilance refers generally to a single patient; however, more than one side effect may have been reported in a report. Therefore, the number of side effects will not always be the same as the number of individual cases.
  • The side-effect reports in EudraVigilance do not represent all available information concerning the benefits and risks of a medicine and should not be used in isolation to make decisions regarding a patient's treatment regimen; other sources of information, including the product/prescribing information, should be consulted first.
  • Patients and consumers should not stop or change medication without prior consultation with a healthcare professional.

 

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