Novartis Gene Therapies
This sponsor has funded 1 studies across 13 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 41853 | Ongoing | A Prospective, Long-Term Registry of Patients with a Diagnosis of Spinal Muscular Atrophy (SMA) - (RESTORE) | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Novartis Gene Therapies
The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.
Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.
PAS by study status
Novartis Gene Therapies
The study status is defined according to the timeline dates specified.
Planned studies have not collected any data yet.
Ongoing studies collect data and should publish protocols as soon as possible.
Finalised studies should publish results in the first two weeks after finalisation.
Countries
Novartis Gene Therapies
13 Study countries specified are the following:
- Argentina
- Brazil
- Chile
- Greece
- Ireland
- Japan
- Korea, Democratic People's Republic of
- Poland
- Portugal
- Romania
- Russian Federation
- Taiwan
- United States