Biotest

This sponsor has funded 9 studies across 9 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
7969 Finalised Not included in RMP Immunoglobulin substitution for infection prevention and treatment of primary and secondary immune deficiency syndromes (German title:... No No
8028 Finalised Non-EU RMP-only A retrospective data collection to increase the knowledge base of posttransplant treatment with the human hepatitis B immunoglobulin Zutectra or... No No
8040 Finalised Not included in RMP Non-interventional prospective safety study as part of the routine pharmacovigilance in patients treated with Intratect 100 g / l (German title:... No No
8060 Finalised Not included in RMP Haemonine - Post marketing study for long-term treatment of Haemophilia B patients (NIS Haemonine) No No
8063 Finalised Non-EU RMP-only Non-interventional study (NIS) for long-term monitoring of the treatment of hemophilia A with Haemoctin SDH (Haemoctin NIS) No No
8116 Finalised Not included in RMP Real Life, Long-term Effectiveness and Safety of Zutectra Self-Administration for HBV Re-Infection Prophylaxis after Liver Transplantation in France... No Yes
13728 Finalised Not included in RMP Non-interventional study of long term treatment with Haemoctin SDH (Biotest NIS-016) Yes Yes
41516 Ongoing Not included in RMP Non-interventional long term study (NIS) for the clinical usage of Biotest IVIGs in various indications (Biotest NIS-020) No No
103611 Ongoing Not included in RMP Documentation of the use of Varitect® CP in patients with herpes zoster, the VARIZOSTA study (NIS-022) No No

PAS by Risk Management Plan (RMP) requirement

Biotest

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.