Stallergenes

This sponsor has funded 5 studies across 9 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
6076 Ongoing Unspecified ALTO, An international non-interventional registry on the quality of life of patients with grass pollen-induced Allergic Rhinitis Treated with... No No
8104 Finalised Not included in RMP An observational study of ORALAIR® (Grass pollen allergen extract from: Cocksfoot, Sweet Vernal, Rye Grass, Meadow Grass, Timothy) tablet for... No Yes
9358 Finalised Not included in RMP Assessment of Oralair® use in real-life (EVORA) No No
43255 Ongoing Not included in RMP Study of the safety and tolerability of STALORAL® Birch and STALORAL® Birch/Alder/Hazel with a maximum dose of 300 IR daily in routine application in... No No
44205 Ongoing Not included in RMP Study of the safety and tolerability of ORYLMYTE in routine practice in adolescents and adults (VORAN) No No

PAS by Risk Management Plan (RMP) requirement

Stallergenes

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.