Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

The aims of pharmacovigilance are to enhance patient care and patient
safety in relation to the use of medicines by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

Pharmacovigilance is based on:

  • the collection of adverse reactions by health professionals, patients, patient associations and approved manufacturers, based on spontaneous reports.
  • the recording and evaluation of these statements.
  • the establishment of surveys or studies to analyze the risks, participation in the establishment and monitoring of risk management plans.
  • the assessment of the safety profile of the medicine based on the data collected.
  • taking corrective measures (precautions or restrictions of use, against-indications or product recall) and communication to health professionals and the public.
  • the communication and dissemination of information relating to the safety of the drug.

AAA’s pharmacovigilance department is located in Saint-Genis-Pouilly, France. It is in continuous contact with health authorities. All our employees are trained to transfer all information related to the safety of our medicines.

Healthcare professionals are also required to immediately report any adverse reaction suspected to be due to a drug.

To report an adverse event, please enter the information required in the Novartis Pharmacovigilance Intake. Please read the Privacy Notice and the Terms of Use.

Report an adverse event