Genentech

This sponsor has funded 6 studies across 2 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
3004 Ongoing Unspecified An Observastional study of Avastin (Bevacizumab) in combination with chemotherapy for treatment of metastatic or locally advanced and unresectable... No No
3014 Planned Non-EU RMP-only An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer No No
3017 Planned Unspecified An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer (AVF4349n) No No
7196 Ongoing Not included in RMP Juvenile arthritis Methotrexate/Biologics long-term Observation (JuMBO) No No
10541 Ongoing EU RMP category 3 The Mycophenolate Pregnancy Registry Yes No
11327 Planned Unspecified RISK OF CARDIOVASCULAR EVENTS IN PATIENTS USING TOCILIZUMAB AS COMPARED WITH OTHER BIOLOGICS IN MULTIPLE LARGE HEALTHCARE DATABASES (EUPAS11327) No No

PAS by Risk Management Plan (RMP) requirement

Genentech

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.