ConcePTION

This sponsor has funded 9 studies across 20 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
43385 Ongoing Not included in RMP Methods for controlling by indication for prescriptions: application to medications for neuropathic pain No No
43409 Planned Not included in RMP Demonstrating solutions for studying intermittent medication exposures in diseases with episodic manifestations during pregnancy: application to... No No
43416 Ongoing Not included in RMP Exposure to SSRI/SNRI and depression in pregnancy and long-term childhood outcomes: the effect of modifying factors Yes No
43420 Ongoing Not included in RMP Novel statistics to handle rare diseases and small sample sizes using Bayesian techniques: Application to Multiple Sclerosis (MS) and Systemic Lupus... No No
45205 Ongoing Not included in RMP Delineating a full phenotype of health, neurodevelopment and adaptive functioning in children and young adults with Fetal Valproate Spectrum Disorder. Yes No
46213 Ongoing Not included in RMP Levocetirizine/cetirizine levels in human milk – an observational, clinical study among breastfeeding women No No
50142 Ongoing Not included in RMP Data characterization of population-based data sources: ConcePTION pipeline Yes No
103385 Ongoing Non-EU RMP-only Prediction of venlafaxine exposure through breastfeeding Yes No
105190 Ongoing Not included in RMP Transfer of metformin into human breast milk and the plasma of breastfeeding children - A low intervention trial with biobanking of breast milk and... No No

PAS by Risk Management Plan (RMP) requirement

ConcePTION

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.