- You have received and read a copy of the VYNDAMAX Product Information
- You agree to explain the risks and benefits of VYNDAMAX compared with existing therapies and/or not taking VYNDAMAX to your patients
- You agree to obtain informed consent from your patients prior to enrolling them in the VYNDAMAX Patient Assistance Program (PAP)
- You may enrol a maximum of 5 patients in the VYNDAMAX PAP within 6 months of the PAP start date
- You are aware that patients enrolled in the VYNDAMAX PAP will receive VYNDAMAX until 1 November 2026 or until VYNDAMAX is listed on the Pharmaceutical Benefits Scheme (PBS), whichever comes first
- You understand that in the event that VYNDAMAX is not listed on the PBS for the patient population enrolled in the VYNDAMAX PAP, Pfizer will continue to supply free VYNDAMAX until 1 November 2026 at which time the program may be reviewed
- You are aware that the VYNDAMAX PAP is only open to adult patients with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) who also meet specific VYNDAMAX PAP patient eligibility criteria
- You understand that you are expected to report suspected adverse events and other safety findings to Pfizer on 1800 734 260, fax 1800 034 314 or email [email protected]
- You understand that you are encouraged to report any adverse events during the VYNDAMAX PAP to the Therapeutic Goods Administration (TGA) at www.tga.gov.au/reportingproblems in accordance with current TGA requirements
- You understand that Pfizer has the right to cease/alter this program at any time. Reasonable notice will be provided in advance of any changes to this program