VII Framework Programme (FP7)

This sponsor has funded 10 studies across 23 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
2221 Ongoing Unspecified EUROmediCAT: Safety of Medication Use in Pregnancy in Relation to Risk of Congenital Malformations No No
2361 Finalised Not included in RMP Arrhythmogenic Potential of Drugs (ARITMO) project Yes Yes
2895 Finalised Not included in RMP Safety Evaluation of Adverse Reactions in Diabetes - Comparative studies (SAFEGUARD) Yes Yes
3099 Finalised Not included in RMP Assessment of the safety of LABAs in asthma in routine care by combining healthcare databases and direct patient follow-up (ASTRO-LAB) Yes Yes
3803 Ongoing Unspecified Long-term observational safety study to evaluate the nature and incidence of adverse effects of deferiprone treatment in patients with... No No
3985 Ongoing Unspecified Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects observational, open label pharmacovigilance study (ADDUCE) No No
4364 Finalised Not included in RMP Safety Evaluation of Adverse Reactions in Diabetes - Drug utilisation studies (SAFEGUARD) Yes Yes
4551 Ongoing Unspecified Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects: Results from the National Health Survey for Children and Adolescents (KiGGS)... No No
4708 Planned Unspecified Over the Counter Codeine Use Misuse and Dependence (CODEMISUSED) Yes No
5383 Finalised Not included in RMP CAncer Risk and INsulin analoGues (CARING) project Yes Yes

PAS by Risk Management Plan (RMP) requirement

VII Framework Programme (FP7)

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.