Safeguarding Patient Health
Continuous safety operations from clinical development through post-approval surveillance — keeping patients protected and your products compliant worldwide.
Continuous Safety Across the Product Lifecycle
Eight focused streams that cover every PV obligation — from system setup and QPPV cover to case processing, signal detection, periodic reports, audits, and database management.
Reporting of Adverse Events or Side Effects
Please report the adverse events or side effects for Regalium products below.
Adverse events or side effects can also be reported to Regalium Pharma Limited at [email protected] or telephone Regalium Pharma on (+351) 920 046 750. Calls may be monitored for training purposes. This information contributes to the continued safety surveillance of our products.
If you prefer, side effects or adverse events can be reported through the Yellow Card scheme. Reporting forms and information can be found at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
If you prefer, you may contact the U.S. Food & Drug Administration (FDA) directly at MedWatch — FDA Safety Information and Adverse Event Reporting Program or call 1-800-FDA-1088 (1-800-332-1088).
A side effect or adverse event is any unwanted medical occurrence in a patient who has been given a Regalium product that may or may not have been caused by treatment with the product. A side effect or adverse event can therefore be any unfavorable and unintended sign, symptom, or disease associated with the use of the product.
If you or the person you are reporting on behalf of is currently experiencing severe side effects or adverse events, you should contact your local doctor or other medical professional before reporting them. Please try to include the product name, batch details, details of the adverse/side effects, patient details, and contact details while reporting side effects or adverse events.
Submit a Report
Your submission will open your email client and be sent directly to our drug safety team.
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