Named Patient Program for Mitomycin for Pyelocalyceal Solution

Sponsor: UroGen Pharma Ltd.

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05494411

This Named Patient Program offers access to JELMYTO for patients in select countries lacking marketing authorization, who have no other treatment options. Eligible patients are those deemed likely to benefit from JELMYTO by their physician. The intervention involves Mitomycin for pyelocalyceal solution, a drug provided under controlled conditions.

Patient Parameters

Program Overview

This program provides controlled, pre-approval access to JELMYTO in response to unsolicited requests by physicians, hospitals, pharmacies, distributors, ministries of health or other parties on behalf of specific, or named patients, in select countries where JELMYTO has not yet received a marketing authorization and in situations when patients have exhausted all available treatment options.

Eligibility Criteria

Inclusion Criteria

  • Patients who are suitable to receive JELMYTO and for whom there is reasonable expectation that JELMYTO may provide clinical benefit based on the medical judgment of their prescribing physician.

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