Managed Access Programs for PKC412, Midostaurin

CPKC412A2407I

The purpose of this registration is to list Managed Access Programs (MAPs) related to PKC4, Midostaurin.

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Inclusion Criteria: * An independent request should be received from a licensed physician (in some instances from Health Authorities, Institutions or Governments). * The patient has a serious or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available for diagnosis, monitoring or treatment; patient is not medically eligible for available treatment alternatives or has exhausted all available treatment options. * The patient is not eligible or able to enroll in a Novartis clinical trial or continue participation in a Novartis clinical trial. * There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated. * The patient must meet any other medical criteria established by the medical experts responsible for the product or by the Health Authority in a country (as applicable). * Provision of the product will not interfere with the initiation, conduct or completion of a Novartis clinical trial or overall development program. * Managed access provision is allowed per local laws/regulations.

{'studyType': 'EXPANDED_ACCESS', 'nPtrsToThisExpAccNctId': 1, 'expandedAccessTypes': {'intermediate': True}}

2024-04-04