Nominative Compassionate Access

What is Nominative Compassionate Use?

At Pierre Fabre Laboratories, we are driven by our company purpose: every time we care for a single person, we make the whole world better.

Pierre Fabre Laboratories’ “Nominative Compassionate Use” addresses the need of treating patients affected by life-threatening or seriously debilitating illnesses by making such medicines available to eligible patients.

Nominative Compassionate Use are nominative accesses, free of charge for the patient and for the entity delivering the product, under which investigational medicines, medicines pending marketing authorization or medicines with no marketing authorization in the requested indication may be used to treat certain patients who cannot enroll in an ongoing clinical trial or Early Access Program (EAP).

What are the conditions of Nominative Compassionate Use?

Pierre Fabre Laboratories is committed to evaluating all Nominative Compassionate Use (NCU) requests that fulfil the conditions below: 

• The request must be unsolicited and addressed by the treating physician on behalf of the patient.
• The regulatory and market access framework in the country is compatible with conditions of such access
• The patient suffers from a life-threatening, long-lasting or seriously debilitating illness.
• All currently available treatment options have been exhausted.
• The patient cannot enroll in an ongoing clinical trial or an Early Access Program (EAP).
• Sufficient clinical data or clinical cases are available to evaluate the benefit/risk balance for the intended use of the medicinal product at the moment of the request.
• Adequate supply of medicinal products is available to ensure treatment continuity in the Nominative Compassionate Use (NCU) and will not interfere with ongoing clinical trial(s) or with the supply in normal conditions of the medicinal product.