RUCONEST® (conestat alfa)
This product has been granted marketed authorization 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
JOENJA® (leniolisib)
This product has been granted marketing authorization by the Food and Drug Administration (FDA) in the United States and by the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom.
Available product information:
- Food and Drug Administration (FDA) in the United States
Package Insert & Patient Product Information - Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom
Summary of Product Characteristics (SmPC) | Patient Information Leaflet (PIL)
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.
Reporting of side effects in the UK: If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at http://www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.