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GENERAL OVERVIEW OF GAMMORA™ MANAGED ACCESS PROGRAM

Zion Medical is committed to developing innovative therapies for patients with HIV. We take our responsibility to act as a true partner with patient communities seriously, and we are committed to working with physicians who have determined that their patient has an unmet medical need.

It has recently been evaluated by certain medical centers that Gammora™, currently licensed for HIV, is being used on an off-label basis for treatment of COVID19 patients with severe respiratory issues. However, Gammora™ is not yet approved anywhere for the treatment of COVID19.

We understand that patients and families may be interested in accessing our therapies prior to regulatory approval, and outside of the clinical trial setting, through a managed access programs (also known as an early / expanded access, or named patient program).

A managed access program (MAP) is a mechanism through which physicians can prescribe, within their professional responsibility, a yet unapproved treatment for patients. Use of an unapproved treatment is based on physicians’ informed assessment of the patients under their care to determine whether there is a special need for the unapproved treatment because (a) there is no approved treatment available or (b) available treatments are not suitable for that patient. For this MAP, physicians will need to assess patient eligibility by determining whether the patient meets pre-specified medical and other criteria and also confirming funding can be secured.

MANAGED ACCESS PROGRAM ELIGIBILITY FOR GAMMORA™

For certain patients in certain jurisdictions, as part of our commitment to facilitating patient access, we support a managed access program in selected geographies where Gammora™ is not currently approved.

All requests must be submitted by the treating physician on behalf of the patient.

 

HOW DO I SUBMIT A REQUEST FOR MANAGED ACCESS?

If you need additional medical information in connection with a request for medication through this program Healthcare providers can obtain details about submitting requests by calling a FarmaMondo representative at +41 91 697 6370, or emailing gammora@farmamondo.com.

 

Gammora was developed by the “Zion Medical” group Click the link to go to the group’s website and get to know more about us

Click here to go to zionmedical.com