Merck Serono

This sponsor has funded 8 studies across 9 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
2353 Finalised Not included in RMP The risk of acute liver injury associated with the use of antibiotics. A methodological comparison across epidemiological data sources Yes No
2356 Finalised Not included in RMP Use of antiepileptics and risk of suicidality. An exploratory study using the UK General Practice Research Database (GPRD) and data from the Danish... Yes Yes
2382 Finalised Not included in RMP Use of antidepressants and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design Yes No
2385 Ongoing Unspecified Use of benzodiazepines and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design. Yes No
2388 Ongoing Unspecified Calcium channel blocker treatments and cancer risk. A methodological protocol to compare the results between databases, across designs: Evaluation of... Yes No
2561 Ongoing Unspecified Use of inhaled long acting beta2 adrenoceptor agonists and the risk for Acute Myocardial Infarction (AMI). A methodological comparison across data... Yes No
13054 Finalised EU RMP category 3 EPID Multiple Sclerosis Pregnancy study - Pregnancy outcomes in Multiple Sclerosis populations exposed and unexposed to interferon beta - a... Yes Yes
26126 Finalised Not included in RMP Safety and Tolerability Evaluation Profile in RMS Patients Starting Rebif New Formulation (STEP) No No

PAS by Risk Management Plan (RMP) requirement

Merck Serono

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.