Shire

This sponsor has funded 13 studies across 22 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
2192 Ongoing Unspecified Burden of AV GRAft and Fistula Complications in chronic kidney disease patients (GRAFIC) No No
7973 Ongoing EU RMP category 1 TED-R13-002: A Prospective, Multi-center Registry for Patients with Short Bowel Syndrome (TED-R13-002: SBS Registry) No No
9200 Finalised Not included in RMP Cohort Study of the Relative Incidence of Major Cardiovascular Events Among Patients Initiating Prucalopride Versus a Matched Comparator Cohort Yes Yes
13269 Finalised Not included in RMP An Open-Label, Randosized, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Profiles of Once-Daily and Twice-Daily Dose Regimens of... Yes Yes
14255 Planned EU RMP category 3 EVALUATION OF THE EFFECTIVENESS OF RISK MINIMISATION MEASURES: A SURVEY AMONG HEALTH CARE PROFESSIONALS AND PATIENT/CAREGIVERS TO ASSESS THEIR... No No
15507 Finalised EU RMP category 3 Drug utilization study for Elvanse® / Tyvense® / Elvanse® Adult in Europe Yes Yes
16927 Ongoing EU RMP category 1 PAR-R13-001: PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Registry for Patients with Chronic Hypoparathyroidism No No
20546 Finalised EU RMP category 2 Cohort Study of the Incidence of Major Cardiovascular Events in New Adult Users of Lisdexamfetamine and Remote Adult Users of Other ADHD Treatments Yes Yes
40684 Finalised Non-EU RMP-only SHP503-803: Drug Utilization Study with Intuniv® in Australia Yes Yes
40690 Finalised Non-EU RMP-only Drug utilization study with VYVANSE® (lisdexamfetamine dimesilate) in Australia for Binge Eating Disorder Yes Yes
42338 Finalised Not included in RMP VPRIV® Non-Interventional Study in Patients Previously Treated with Other Enzyme Replacement Therapies (ERTs)/Substrate Reduction Therapies (SRTs)... Yes Yes
48713 Ongoing Non-EU RMP-only TAK-834-4008: Quantitative Testing of Patient and Healthcare Provider Knowledge, Attitudes, and Behavior About NATPARA® (Parathyroid Hormone) for... No No
48716 Ongoing Non-EU RMP-only TAK-633-4008: Quantitative Testing of Patient and Prescriber Knowledge, Attitudes, and Behavior about GATTEX (Teduglutide) for Injection Safety and... No No

PAS by Risk Management Plan (RMP) requirement

Shire

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.