West’s SelfDose® patient-controlled injector is not independently cleared or approved by any Regulatory Body for general healthcare professional or patient use, nor is it available for general commercial purchase. Its distribution and use are subject to applicable regulatory requirements for clinical investigation, and for marketing authorization, as used in combination with a specific drug or biological product. Each component of a combination product is subject to the requirements established by the Regulatory Body for that component (drug, biologic or device). The regulatory process can be more complicated for combination products including an evaluation of the product characteristics, delivery system and its functionality, as well as the potential for undesirable interactions between the drug or biologic and the delivery system. As a result, we note that the SelfDose® patient-controlled injector's compatibility with any particular drug or biologic must be confirmed, and its ability to achieve the desired patient benefits must also be confirmed, on a case-by-case basis in a manner sufficient to meet Regulatory Body requirements. The assembled appearance of the SelfDose® patient-controlled injector is for demonstrative purposes only. The SelfDose® patient-controlled injector is intended to be distributed as an integrated device and is provided disassembled for assembly with, or around, the specific drug or biologic
SelfDose™ is a trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
SmartDose® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
West markets SmartDose® as a multi-component system only. Final assembly of the prefilled component is completed by the pharmaceutical company.
English
Chinese
