Products

This product has been approved for use by the European Medicines Agency (EMA) in Europe, the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom and the Food and Drug Administration (FDA) in the United States.

Available product information:

• European Medicines Agency (EMA) in Europe
  European Public Assessment Report (EPAR): ENGLISH | DUTCH

• Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom
  Summary of Product Characteristics (SmPC) | Patient Information Leaflet (PIL)

• Food and Drug Administration (FDA) in the United States
  Package Insert & Patient Product Information

This product has been approved for use by the Food and Drug Administration (FDA) in the United States.

Available product information:

• Food and Drug Administration (FDA) in the United States
  Package Insert & Patient Product Information

REPORT AN ADVERSE EVENT

For Pharming as a global biopharmaceutical company, ensuring patient safety is our number one goal, beyond mere compliance with worldwide regulations. By reporting adverse events for Pharming medicinal products, you help us to ensure the safety of our products. Your information will also enable Pharming to fulfill its reporting requirements to Health Authorities, which requires that Pharming provides information on adverse events with our products.

In case you experience or suspect any adverse event following the administration of our product(s), please contact Pharming.