Phone
Acknowledgement
5 Days
EA Therapies for Single Patient
Maraciclatide is an in vivo imaging agent (non-therapeutic) for use in endometriosis.
EA Policies for Single Patient
Serac Healthcare will consider providing a requesting physician with pre-approval access to the Serac Healthcare investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met.
- The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational product and the benefit outweighs the known or anticipated risks
- The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition
- Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access
- Adequate supply of the investigational drug is available
- No viable alternative option is available