Safety

Safety

Reporting Possible Side Effects

Y-mAbs take patient safety very seriously, and it is vital for us to continuously monitor the safety of our products. Hearing about your experiences helps us to ensure the safety of our products and to offer the best possible advice to those using Y-mAbs products.

How to Report a Possible Side Effect

Please contact us at 1-833-33YMABS (1-833-339-6227).
Reports can be made directly to FDA as well at www.fda.gov/medwatch or 1-800-FDA-1088 (1-800-332-1088).

To help us process your report effectively, please report as much relevant information as possible. Please ensure to include the following minimum information:

About the Person Submitting the Information:

  • Your name and contact information
  • Your role e.g. physician, nurse, other healthcare professional, patient or relative
  • Whether Y-mAbs may contact you for additional information
  • If you are a patient or relative, may Y-mAbs contact your/your relative’s physician. If yes kindly provide name and contact information

About the Person Who Experienced the Adverse Event:

  • Person’s initials, gender, date of birth or age

About the Drug and the Adverse Event:

  • Name of the drug, date(s) of treatment and dosage information, if known
  • Description of the side effect, when did it occur, the outcome of the event and any treatment received due to the side effect

If you have any questions about your own or relative’s treatment or health condition, kindly contact your treating physician or the health care system.

Y-mAbs and patient safety

At Y-mAbs we are committed to ensure patient safety

In patient safety, we are dedicated to the detection, assessment, understanding and management of adverse effects. We continuously monitor the safety profile of our products and ensure appropriate communication of safety information to health care professionals, patients, and regulatory agencies.

To live up to our responsibilities and safeguard patient safety, the following Y-mAbs functions/role have been established.

Clinical Drug Safety
This function manages a global system for the collection, review and reporting of adverse experience reports and other safety data received from worldwide clinical trials ensuring compliance with regulatory requirements.

Post Marketing Pharmacovigilance
This function manages a global system for the collection, review and reporting of adverse experience reports received from marketed products and the continuous assessment of product safety.

Chief Medical Officer
Our company’s chief medical officer holds overall responsibility for the benefit/risk of our pipeline and marketed products, provides medical oversight for all clinical programs, supervises the development and implementation of medical policies, including those related to data transparency and the sharing of clinical data, and has responsibility for the design of pre-registration expanded access (“compassionate use”) programs.