Amicus Therapeutics
This sponsor has funded 2 studies across 32 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 38668 | Ongoing | A Global Prospective Observational Study Of Women With Fabry Disease And Their Infants During Pregnancy And Breastfeeding (AT1001-037) | No | No |
| 107299 | Planned | A GLOBAL PROSPECTIVE OBSERVATIONAL REGISTRY OF PATIENTS WITH POMPE DISEASE | No | No |
PAS by Risk Management Plan (RMP) requirement
Amicus 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
Amicus 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
Amicus Therapeutics
32 Study countries specified are the following:
- Argentina
- Australia
- Austria
- Belgium
- Bosnia and Herzegovina
- Brazil
- Canada
- Chile
- Czechia
- Denmark
- Estonia
- France
- Germany
- Greece
- Hungary
- Israel
- Italy
- Japan
- Korea, Republic of
- Netherlands
- New Zealand
- Poland
- Portugal
- Serbia
- Slovakia
- Slovenia
- Spain
- Sweden
- Taiwan
- Thailand
- United Kingdom
- United States