Recordati Rare Diseases

This sponsor has funded 5 studies across 10 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
3199 Ongoing EU RMP category 3 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 EU RMP category 3 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 Not included in RMP 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 Not included in RMP 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 Not included in RMP 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.