Novo Nordisk

This sponsor has funded 22 studies across 34 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
3687 Finalised EU RMP category 3 NN1841-3868 Use of rFXIII in treatment of congenital FXIII deficiency, a prospective multi-centre observational study (mentor™6) Yes Yes
4122 Finalised EU RMP category 3 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 EU RMP category 3 NN304-4016 An international non-interventional prospective cohort study to evaluate the safety of treatment with Levemir® (insulin detemir) in... Yes Yes
5501 Finalised EU RMP category 3 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 Not included in RMP NN1250-4129 A multi-centre, prospective, open-label, single-arm, non-interventional, post marketing surveillance (PMS) study of Tresiba® (insulin... Yes Yes
6587 Finalised Not included in RMP 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 Not included in RMP 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 Not included in RMP 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 EU RMP category 3 NN8022-4241 In-market utilisation of liraglutide used for weight management in Europe: a retrospective medical record review study Yes Yes
23369 Finalised EU RMP category 3 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 Not included in RMP NN7999-4413: Adverse Event Data Collection from External Registries on Nonacog Beta Pegol Yes No
26592 Ongoing EU RMP category 1 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 Not included in RMP 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 EU RMP category 3 NN7088-4557: Adverse Event Data Collection from the EUHASS Registry on Turoctocog alfa pegol Yes No
35429 Finalised Not included in RMP NN7711-4729 Clinical outcomes of NovoSeven® treatment in severe postpartum haemorrhage – a retrospective single-centre cohort study at the University... Yes Yes
36536 Ongoing EU RMP category 1 NN7088-4029 A multinational, prospective, open labelled, non-controlled, non-interventional post-authorisation study of turoctocog alfa pegol (N8-GP)... Yes No
37258 Ongoing EU RMP category 3 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 Not included in RMP 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 EU RMP category 3 Medullary Thyroid Carcinoma Surveillance Study: a Case-Series Registry (H9X-MC-B001) Yes No
46223 Ongoing EU RMP category 3 GH-4831: CROITRE Registry :French registry of children treated with Norditropin® for short stature associated with Noonan Syndrome Yes No
104526 Ongoing EU RMP category 3 NN8640-4515 A multi-national, multi-centre, prospective, single-arm, observational, non-interventional post-authorisation safety study to investigate... Yes No
104613 Ongoing Non-EU RMP-only 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.