PTC Therapeutics
This sponsor has funded 2 studies across 19 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 11275 | Ongoing | Not included in RMP | Long-Term Observational study of Translarna Safety and Effectiveness in Usual Care (STRIDE) | No | No |
| 105422 | Ongoing | EU RMP category 2 | A Two-Part, International, Real-World, Observational Registry of Participants Diagnosed with Aromatic L-Amino Acid Decarboxylase Deficiency (AADC-d)... | No | No |
PAS by Risk Management Plan (RMP) requirement
PTC Therapeutics
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
PTC Therapeutics
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
PTC Therapeutics
19 Study countries specified are the following:
- Austria
- Brazil
- Czechia
- France
- Germany
- Greece
- Hungary
- Israel
- Italy
- Latvia
- Portugal
- Romania
- Saudi Arabia
- Slovenia
- Spain
- Sweden
- Türkiye
- United Kingdom
- United States