Octapharma

This sponsor has funded 5 studies across 24 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
7687 Finalised Not included in RMP Non-interventional safety study on the tolerability and safety of octagam® 5%, octagam® 10% or panzyga® No Yes
7905 Finalised EU RMP category 3 Prospective, multinational, non-interventional post-authorisation study to document the long-term immunogenicity, safety, and efficacy of Human-cl... No No
10738 Ongoing Unspecified Postmarketing Requirement (PMR) Non-Interventional 2-armed Study to Evaluate the Safety of octagam® Immune Globulin Intravenous (Human) 5% Liquid... Yes No
12560 Finalised EU RMP category 3 Surveillance of Safety and Efficacy of wilate® in patients with von Willebrand disease (Wil-20) No No
29946 Finalised Not included in RMP A Prospective, Multicentre, Non-Interventional Study Evaluating the Bleeding Incidence in Patients with Von Willebrand Disease Undergoing On-Demand... No No

PAS by Risk Management Plan (RMP) requirement

Octapharma

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.