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Pharmaceutical products need to be as safe as possible and fully compliant with regulatory guidelines. Therefore, in the development of pharmaceutical products, the evaluation of safety and efficacy of these products is mandatory. Several studies need to be performed. These studies are highly regulated and thoroughly monitored, reviewed, and evaluated both by Baxalta Pharmaceutical Company and the Health Authorities.

All pharmaceutical products, e.g. RUCONEST®, can cause side effects. However, not all side effects (adverse events) associated with the use of pharmaceutical products can be detected during clinical development, not even by the most comprehensive clinical trials. Capturing as many of these adverse events, however rare they may be, from worldwide sources is of paramount importance for continued patient safety.

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

US and US territories:
Phone (Monday to Friday 6.00 a.m. to 4.00 pm): +1 (800) 930-5221 
e-mail: [email protected]
Fax: +1 201-389-8092

You can also report (suspected) adverse events to the FDA at 1-800-FDA-1088 or visit

EU and Rest of World territories:
Phone (24/7 availability): +31 (0)71 5247 110
e-mail: [email protected]
Fax: +31 (0)85 0643 382  

All the information and personal data you share with us will be protected and kept confidential in line with our company standard operating procedures and applicable national and European data protection regulations. The information you provide will be used for the purpose of drug safety surveillance and to enable us to deal with your report appropriately. To understand how we collect and process your data when you submit an adverse event, please read our Privacy statement

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