Genzyme

This sponsor has funded 16 studies across 22 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
7574 Finalised EU RMP category 3 International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis (OBS13436) Yes Yes
9194 Finalised EU RMP category 3 A Prospective Safety Sub-Registry to Assess Anaphylaxis and Severe Allergic Reactions, and Severe Cutaneous and Systemic Immune-Mediated Reactions... Yes Yes
10301 Finalised EU RMP category 3 Myozyme (alglucosidase alfa) Safety Information Packet effectiveness evaluation: a health care professional survey Yes Yes
10526 Finalised EU RMP category 3 Prevalence of immunology testing in patients treated with alglucosidase alfa with significant hypersensitivity/anaphylactic reactions (ALGMYC07390) Yes Yes
11998 Ongoing EU RMP category 1 A prospective multicenter observational post authorization safety sub-registry to characterize the long-term safety profile of commercial use of... Yes No
21025 Finalised EU RMP category 3 Drug Utilization Study of eliglustat in the US population using MarketScan® Database (ELIGLC06912) Yes Yes
23142 Finalised EU RMP category 3 Fabrazyme (agalsidase beta) home infusion educational materials effectiveness evaluation: a survey for healthcare providers and patients/caregivers... Yes Yes
34611 Planned EU RMP category 3 Drug utilisation study of Eliglustat for the treatment of Gaucher Disease Type 1 in Europe using electronic healthcare records (ELIGLC06913) No No
42540 Ongoing EU RMP category 1 A NON-INTERVENTIONAL POST-AUTHORISATION SAFETY STUDY TO INVESTIGATE DRUG UTILISATION AND SAFETY MONITORING PATTERNS FOR LEMTRADA (ALEMTUZUMAB) Yes No
42543 Ongoing EU RMP category 1 A non-interventional post-authorisation safety study to investigate the risk of mortality in multiple sclerosis patients treated with alemtuzumab... Yes No

PAS by Risk Management Plan (RMP) requirement

Genzyme

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.