Mylan

This sponsor has funded 11 studies across 21 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
9827 Planned EU RMP category 3 Drug utilisation study (DUS) on the use of Cholib® (fenofibrate and simvastatin fixed combination): a European multinational study using secondary... No No
9983 Ongoing Not included in RMP Observational pharmaco-epidemiological study on the use of Izalgi® No No
10541 Ongoing EU RMP category 3 The Mycophenolate Pregnancy Registry Yes No
11707 Finalised Not included in RMP The Effectiveness and Safety of Single 6ml Hyaluronic Acid Intra-articular Injection (Suplasyn® 1-shot) in Managing Symptomatic Primary Osteoarthritis... Yes Yes
11712 Finalised Not included in RMP The Effectiveness and Safety of Triple 2ml Hyaluronic Acid Intra-articular Injection (Suplasyn®) in Managing Symptomatic Primary Osteoarthritis of the... Yes Yes
11765 Finalised EU RMP category 1 Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey among Health Care Professionals to Assess their Knowledge and... Yes Yes
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
15741 Planned EU RMP category 3 Assessment of Health Care Professionals’ Knowledge and Behaviour Regarding Prescribing Conditions of Cholib® (fenofibrate and simvastatin fixed... No No
24731 Finalised Not included in RMP Etude d’impact de la communication menée auprès des médecins prescripteurs d’Epitomax® et ses génériques en France No No
30940 Ongoing Not included in RMP Effectiveness of Dymista® in patients with allergic rhinitis and asthma No No
32142 Ongoing EU RMP category 3 Prescriber survey to evaluate the awareness to risk minimisation measures for mitoxantrone-containing medicinal products in the treatment of patients... No No

PAS by Risk Management Plan (RMP) requirement

Mylan

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.