Stada Arzneimittel

This sponsor has funded 8 studies across 13 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
7619 Finalised EU RMP category 3 Risk of Venous Thromboembolism and All-Cause Mortality in Cancer Patients Treated with Epoetins either with or without Transfusions versus Cancer... No Yes
10254 Finalised Not included in RMP Thromboembolic Risk in Patients with Chronic Kidney Disease Treated receiving Epoetin zeta or other Erythropoietin Stimulating Agents – the BIPS study Yes No
12171 Ongoing EU RMP category 1 Retrospective Cohort Study on the Risk of Venous Thromboembolism with the use of combined oral contraceptives containing Chlormadinone... No No
31817 Finalised Not included in RMP Retrospektive Ärztebefragung zu Vorkommen und Ursachen von Stürzen bei älteren Patienten unter besonderer Betrachtung von Antihistaminika der ersten... No No
33796 Ongoing EU RMP category 3 A pregnancy exposure registry study to assess clinical follow-up and outcomes of pregnancies exposed to ulipristal acetate 30 mg. Yes No
35589 Finalised Not included in RMP Apothekenbasierte, nicht-interventionelle Unbedenklichkeitsprüfung von Hoggar® Night Tabletten/Schmelztabletten unter Alltagsbedingungen (Projekt... No No
45747 Ongoing EU RMP category 3 Monitoring of the Lenalidomide Pregnancy Prevention Programme (PPP) Implementation and Effectiveness in Germany (Lena-PIE Germany) No No
49520 Ongoing EU RMP category 3 Monitoring of the Lenalidomide Pregnancy Prevention Programme (PPP) Implementation and Effectiveness in Europe (Lena-PIE Europe) No No

PAS by Risk Management Plan (RMP) requirement

Stada Arzneimittel

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.