Krka d.d.
This sponsor has funded 2 studies across 7 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 39805 | Ongoing | EU RMP category 3 | Active surveillance of overdose with a prolonged-release formulation of tramadol/paracetamol. The PICS study. | No | No |
| 47961 | Planned | EU RMP category 3 | A drug utilisation study to assess the effectiveness of risk minimisation measures and describe the prescribing practices of Doreta SR and ... | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Krka d.d.
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
Krka d.d.
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
Krka d.d.
7 Study countries specified are the following:
- Czechia
- Hungary
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia