Novo Nordisk

This sponsor has funded 22 studies across 34 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
3687 Finalised NN1841-3868 Use of rFXIII in treatment of congenital FXIII deficiency, a prospective multi-centre observational study (mentor™6) Yes Yes
4122 Finalised PDS290 Focused Usability Test of colour-blind individuals’ ability to differentiate between Tresiba® 100 units/mL FlexTouch®, Tresiba® 200 units/mL... Yes Yes
4137 Finalised NN304-4016 An international non-interventional prospective cohort study to evaluate the safety of treatment with Levemir® (insulin detemir) in... Yes Yes
5501 Finalised NN7008-3553 A Multi-centre Non-interventional Study of Safety and Efficacy of turoctocog alfa (rFVIII) during Long-Term Treatment of Severe and... Yes Yes
6318 Finalised NN1250-4129 A multi-centre, prospective, open-label, single-arm, non-interventional, post marketing surveillance (PMS) study of Tresiba® (insulin... Yes Yes
6587 Finalised NN5401-4149 A multi-centre, open-label, single-arm, non-interventional, post marketing sur-veillance (PMS) study of insulin degludec /insulin aspart... Yes Yes
7880 Finalised NN1250-4189 A multi-centre, prospective, non-interventional study of insulin degludec investigating the safety and effectiveness in a real world... Yes Yes
8135 Finalised NN2211-4077 Retrospective collection of effectiveness and safety data from patients treated with liraglutide or DPP-4 inhibitor in primary care in... Yes Yes
16225 Finalised NN8022-4241 In-market utilisation of liraglutide used for weight management in Europe: a retrospective medical record review study Yes Yes
23369 Finalised NN8022-4246 In market utilisation of liraglutide used for weight management in the UK: a study in the CPRD primary care database Yes Yes
25696 Ongoing NN7999-4413: Adverse Event Data Collection from External Registries on Nonacog Beta Pegol Yes No
26592 Ongoing NN7999-4031: A Non-Interventional Post-Authorisation Safety Study (PASS) in male haemophilia B patients receiving Nonacog Beta Pegol (N9-GP)... Yes No
29708 Finalised NN304-4528: Retrospective Cohort study of all-Cause and Cardiovascular Mortality in type 2 diabetes patients using basal insulin Detemir and Glargine Yes Yes
33777 Ongoing NN7088-4557: Adverse Event Data Collection from the EUHASS Registry on Turoctocog alfa pegol Yes No
35429 Finalised NN7711-4729 Clinical outcomes of NovoSeven® treatment in severe postpartum haemorrhage – a retrospective single-centre cohort study at the University... Yes Yes
36536 Ongoing NN7088-4029 A multinational, prospective, open labelled, non-controlled, non-interventional post-authorisation study of turoctocog alfa pegol (N8-GP)... Yes No
37258 Ongoing NN9535-4447 Epidemiological assessment of the risk for pancreatic cancer associated with the use of semaglutide in patients with type 2 diabetes- A... No No
44951 Ongoing VAG-4602: Vaginal estradiol tablets (Vagifem®) and endometrial cancer risk in the treatment of postmenopausal vaginal atrophy: A register-based cohort... Yes No
45076 Ongoing Medullary Thyroid Carcinoma Surveillance Study: a Case-Series Registry (H9X-MC-B001) Yes No
46223 Ongoing GH-4831: CROITRE Registry :French registry of children treated with Norditropin® for short stature associated with Noonan Syndrome Yes No
104526 Ongoing NN8640-4515 A multi-national, multi-centre, prospective, single-arm, observational, non-interventional post-authorisation safety study to investigate... Yes No
104613 Ongoing NN9536-4937 Wegovy® (semaglutide 2.4 mg) Pregnancy Registry Study: A Prospective Cohort Study to Investigate Safety Outcomes of Exposure to Wegovy... Yes No

PAS by Risk Management Plan (RMP) requirement

Novo Nordisk

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.