Pharmacovigilance

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

We inform you that the personal data you provide by sending this e-mail will be processed in compliance with ARTICLES 13 AND 14 OF REGULATION (EU) 2016/679 (GDPR) as referred to in the privacy policy on our website and which recalls the confidentiality obligations that inspire our company’s activity in order to be able to respond quickly and comprehensively to your request.

The processing of your personal data will be carried out using appropriate tools to ensure the security and confidentiality of the aforementioned data.

The methods of processing of data referred in this notice to here provide for applies for the use of manual, computerized and telematic tools.

Your data will be processed by employees and / or collaborators of AAA duly appointed for processing. Furthermore, AAA is part of a multinational Group, therefore it may be that your personal data are transferred to other countries, even outside the European Union, to parent companies, subsidiaries or affiliates, as well as to external service companies, even if only for technical-IT reasons. In these cases we will proceed to their transfer only in the presence of the provision of your consent.

The optional, explicit and voluntary sending of e-mail address or other data entered in the contact form to the official addresses indicated on this site entails the subsequent acquisition of the sender’s e-mail address necessary to respond to requests, as well as any other personal data entered. Specific summary information could be progressively reported or displayed on the pages of the website prepared for particular services on request.

The user confers the widest indemnity with respect to any objection, claim request for compensation for damage from treatment that should be received by the Data Controller from any third party concerned due to the provision of data indicated by the user in violation of the rules on protection of the personal data applicable according to the GDPR 2016/679.

THE REGULATION (EU) 2016/679 includes measures to protect and guarantee your rights, in particular, the interested party has the right at any time to obtain confirmation of the existence of personal data concerning him/her and to know its content and origin, verify its accuracy or request its integration or updating, or rectification. It also has the right to request the cancellation, transformation into anonymous form or blocking of data processed in violation of the law, as well as to oppose in any case, for legitimate reasons, to their processing. You may exercise these rights at any time by contacting us at: dataprivacy.aaa@novartis.com.

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