COMPANY
Novo Nordisk A/S
Novo Nordisk A/S: marketing authorisation holder, bulk ingredient labeler, US labeler, trial sponsor for Insulin degludec, Liraglutide, Semaglutide, Cagrilintide, Calcitonin, Ciclosporin, Dulaglutide, Exenatide, Glucagon, Lixisenatide, Tirzepatide, as stated by public registers.
MARKETING AUTHORISATION HOLDER
Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).
| Insulin degludec | Ryzodeg (EMEA/H/C/002499), Authorised Regulator EMA |
|---|---|
| Insulin degludec | Tresiba (EMEA/H/C/002498), Authorised Regulator EMA |
| Liraglutide | Saxenda (EMEA/H/C/003780), Authorised Regulator EMA |
| Liraglutide | Victoza (EMEA/H/C/001026), Authorised Regulator EMA |
| Liraglutide | Xultophy (EMEA/H/C/002647), Authorised Regulator EMA |
| Semaglutide | Kayshild (EMEA/H/C/006426), Authorised Regulator EMA |
| Semaglutide | Kyinsu (EMEA/H/C/006279), Authorised Regulator EMA |
| Semaglutide | Ozempic (EMEA/H/C/004174), Authorised Regulator EMA |
| Semaglutide | Rybelsus (EMEA/H/C/004953), Authorised Regulator EMA |
| Semaglutide | Wegovy (EMEA/H/C/005422), Authorised Regulator EMA |
BULK INGREDIENT LABELER
Lists the bulk active ingredient with FDA (NDC directory).
| Liraglutide | Liraglutide, BULK INGREDIENT Regulator openFDA |
|---|---|
| Semaglutide | Semaglutide, BULK INGREDIENT Regulator openFDA |
US LABELER
Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.
| Semaglutide | Semaglutide SNAC, DRUG FOR FURTHER PROCESSING Regulator openFDA |
|---|---|
| Semaglutide | semaglutide, DRUG FOR FURTHER PROCESSING Regulator openFDA |
| Semaglutide | Semaglutide, DRUG FOR FURTHER PROCESSING Regulator openFDA |
TRIAL SPONSOR
Sponsors registered clinical trials of the peptide.
| Cagrilintide | 22 registered trials Trial register EU CTIS |
|---|---|
| Cagrilintide | 40 registered trials Trial register ClinicalTrials.gov |
| Calcitonin | 2 registered trials Trial register EU CTIS |
| Ciclosporin | 1 registered trial Trial register ClinicalTrials.gov |
| Dulaglutide | 3 registered trials Trial register ClinicalTrials.gov |
| Exenatide | 5 registered trials Trial register ClinicalTrials.gov |
| Glucagon | 6 registered trials Trial register ClinicalTrials.gov |
| Insulin degludec | 144 registered trials Trial register ClinicalTrials.gov |
| Insulin degludec | 2 registered trials Trial register EU CTIS |
| Liraglutide | 1 registered trial Trial register EU CTIS |
| Liraglutide | 139 registered trials Trial register ClinicalTrials.gov |
| Lixisenatide | 1 registered trial Trial register ClinicalTrials.gov |
| Semaglutide | 256 registered trials Trial register ClinicalTrials.gov |
| Semaglutide | 37 registered trials Trial register EU CTIS |
| Tirzepatide | 1 registered trial Trial register EU CTIS |
| Tirzepatide | 4 registered trials Trial register ClinicalTrials.gov |
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