Recordati Rare Diseases

This sponsor has funded 5 studies across 10 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
3199 Ongoing Non-interventional study for the generation of long term safety and efficacy data of pasireotide s.c. in patients with Cushing’s disease... No No
25688 Planned Open-label, longitudinal, post-authorisation safety study to assess the safety of Cystadrops in pediatric and adult cystinosis patients in long term... No No
38484 Ongoing Effectiveness and tolerability of high-dose methocarbamol vs. typical strong and long-acting opioidanalgesics (LAO) as add-on measure in patients with... No No
46496 Ongoing A non-interventional study to assess the long-term safety and efficacy of osilodrostat in patients with endogenous Cushing’s syndrome (LINC 6) No No
50070 Ongoing Efficacy and tolerability of the non-benzodiazepine antispasmodic methocarbamol for the short-term treatment of acute low back pain over 3 days -... No No

PAS by Risk Management Plan (RMP) requirement

Recordati Rare Diseases

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.