Santen

This sponsor has funded 2 studies across 14 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
22204 Finalised Preservative-free fixed-dose combination of tafluprost 0.0015% / timolol 0.5% in patients with open-angle glaucoma or ocular hypertension: Clinical... Yes No
22376 Ongoing Cyclosporine 1mg/ml eye drop emulsion (Ikervis®) for the treatment of severe keratitis in adult patients with dry eye disease, which has not improved... Yes No

PAS by Risk Management Plan (RMP) requirement

Santen

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.