CSL Seqirus

This sponsor has funded 5 studies across 12 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
29472 Finalised EU RMP category 3 A Prospective Observational Safety Study on Pregnancy Outcomes in Women Immunized With Seasonal Cell Culture Influenza Trivalent (TIVc) or... No No
29817 Finalised Not included in RMP DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2018/19 (DRIVE 2018/19) Yes Yes
35685 Finalised Not included in RMP DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2019/20 (DRIVE 2019/20) Yes Yes
40875 Finalised Not included in RMP DRIVE Brand-specific influenza vaccine effectiveness in Europe, season 2020/21 (DRIVE 2020/21) Yes Yes
46888 Finalised Not included in RMP DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2021/22 (DRIVE 2021/22) Yes Yes

PAS by Risk Management Plan (RMP) requirement

CSL Seqirus

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.