Primary Immune Thrombocytopenia, Sjögren's Syndrome
Conditions
Keywords
MAP, Managed Access Program, VAY736, ianalumab, Primary Immune Thrombocytopenia (ITP), Sjögren's Syndrome (SjD), Expanded Access, Early Access, Compassionate use
Brief summary
The purpose of this registration is to list Managed Access Programs (MAPs) related to VAY736, ianalumab
Detailed description
* CVAY736I12003M - Available - Managed Access Program (MAP) Cohort Treatment Plan CVAY736I12003M to provide access to ianalumab (VAY736) for patients with Primary Immune Thrombocytopenia (ITP) * CVAY736A1002M - Available - Managed Access Program (MAP) Cohort Treatment Plan CVAY736A1002M to provide access to ianalumab for adult patients with Sjögren's disease * CVAY736A1003I - Available - Managed Access Program (MAP) Individual Patient Request (IPR) Cover Letter CVAY736A1003I to provide access to Ianalumab (VAY736) for Sjögren's Disease * CVAY736I12004I - Available - Managed Access Program (MAP) Individual Patient Request (IPR) Cover Letter CVAY736I12004I to provide access to Ianalumab (VAY736) for Primary Immune Thrombocytopenia (ITP) and Evans syndrome
Interventions
DRUGianalumab
Patients receive ianalumab
Sponsors
Novartis Pharmaceuticals
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. An independent request was received from a licensed physician. 2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment. 3. The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial. 4. 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. 5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable). 6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program. 7. Managed Access provision is allowed per local laws/regulations.
Contacts
CONTACTMAP requests are initiated by a licensed physician. https// www.novart is.com/healthcare-professionals/managed-access-programs
CONTACTNovartis Pharmaceuticals
Outcome results
None listed