long-acting insulin analogue
Is Insulin degludec legal?
Answer
Insulin degludec is authorised or registered in 10 of the 10 registers read: United States, European Union, United Kingdom, Canada, Australia, Switzerland, Brazil, Serbia, Singapore, Turkey.
Each row is what that country's own register said on the date shown. Not legal advice.
| Country | Status | Products on the register | Register | Read |
|---|---|---|---|---|
| United States | FDA-approved | Xultophy, Tresiba, Insulin Degludec | Regulator FDA | 2026-10-03 |
| European Union | Authorised | Tresiba | Regulator EMA | 2026-10-03 |
| United Kingdom | Authorised | Tresiba, Xultophy | Regulator MHRA | 2026-10-03 |
| Canada | Authorised | Tresiba | Regulator Health Canada | 2026-10-03 |
| Australia | Registered | Ryzodeg, Tresiba, Tresiba Penfill | Regulator TGA | 2026-10-03 |
| Switzerland | Authorised | Ryzodeg FlexTouch , Injektionslösung, Ryzodeg Penfill, Injektionslösung, Tresiba FlexTouch, Tresiba Penfill, Injektionslösung | Regulator Swissmedic | 2026-10-03 |
| Brazil | Registado | Tresiba | Regulator ANVISA | 2026-10-03 |
| Serbia | Authorised | insulin degludek, insulin degludek, insulin aspart, insulin degludek, liraglutid | Regulator ALIMS | 2026-09-03 |
| Singapore | Registered | Insulin Degludec, Insulin Aspart&&Insulin Degludec | Regulator HSA | 2026-09-03 |
| Turkey | Ruhsatli | Insulin Degludek | Regulator TITCK | 2026-09-03 |
A country not listed has no register read yet; see the world map. EU decisions also apply in Iceland, Liechtenstein and Norway.
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