Swedish Orphan Biovitrum

This sponsor has funded 4 studies across 24 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
3636 Finalised EU RMP category 3 A non-interventional Post Authorization Safety Study (PASS) to evaluate long-term safety of Orfadin treatment in hypertyrosinemia type 1 (HT-1)... Yes Yes
6366 Finalised EU RMP category 3 A non-interventional, post authorization safety study (PASS) to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic... Yes Yes
9339 Finalised EU RMP category 3 Effectiveness of Xiapex® educational material for healthcare professionals in the treatment of Peyronie’s disease - a non-interventional... No No
28378 Finalised EU RMP category 3 A non-interventional, post-authorization safety study (PASS) to evaluate long-term safety of anakinra (Kineret®) in patients with systemic juvenile... Yes Yes

PAS by Risk Management Plan (RMP) requirement

Swedish Orphan Biovitrum

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.