Patients & Health care professionals

Pharmacovigilance – Side Effects

All medicines have benefits and potential risks. Onxeo has the responsibility, for the sake of patient safety:

  • To identify, assess and make agreements with national and international health authorities in order to reduce these risks
  • To ensure that the overall benefit of its medicine is greater than potential risks. This vigilance must be in place throughout the drug’s life cycle.

The Pharmacovigilance of Onxeo ensures continuous monitoring for adverse effects of drugs. Risk situations are monitored carefully such as misuse, abuse, overdose, medication errors and the use during pregnancy or while breastfeeding.

Onxeo’s Pharmacovigilance Department is working in close collaboration with health professionals, competent health authorities (national health agencies such as the ANSM), the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and the patient community, in order to prevent and reduce risks to patient safety and optimise the risk/benefit ratio of its medicines.

The Pharmacovigilance Department also has the responsibility of informing physicians and patients about any potential risks associated with a drug.

In order to fulfil its mission, Onxeo needs to gather all available information on its medicines:

To report a case of pharmacovigilance, you can reach us:

  • At the e-mail address: pharmacovigilance@onxeo.com
  • By mail or phone 24/24: Onxeo
    Pharmacovigilance Department
    49, Boulevard du General Martial Valin
    75015 Paris, France
    Phone: +33 (0)1 45 58 76 00
  •  Health care professionals must immediately report any suspected adverse reaction to a medicinal product which they have become aware of to their local health authority or to the pharmaceutical company that markets it.
  • Patients and accredited patient associations may report any adverse reactions suspected of being due to a drug to their local health authority.