Tresiba Novo Nordisk A/S · Authorised · authorised 20 Jan 2013 · ATC A10AE06
Therapeutic indication (EMA)
Treatment of diabetes mellitus in adults.
Active substance
Insulin degludec
- SFDA 3
- US FDA 1
- EMA 1
- Health Canada 3
- US price lines 2
- NHS prices 2
- WHO EML 1
- Safety 9
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| TRESIBA FlexTouch 100 U/ml solution for injection | 100 IU/ml | Solution for injection · Subcutaneous use | 5 Pre-filled pen | SAR 359.95 | NCE · Prescription | NOVO NORDISK | Valid |
| Tresiba FlexPen | 100 U/ml | Solution for injection in pre-filled pen · Subcutaneous use | 5 Pre-filled pen | SAR 359.95 | Biological · Prescription | NOVO NORDISK | Valid |
| TRESIBA FlexTouch 200 U/ml solution for injection | 200 U/ml | Solution for injection in pre-filled pen · Subcutaneous use | 3 Cartridge | SAR 454.70 | NCE · Prescription | NOVO NORDISK | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
DIABETES MELLITUS TYPE 1; DIABETES MELLITUS TYPE 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| TRESIBA | 300 UNITS/3ML (100 UNITS/ML); 600 UNITS/3ML (200 UNITS/ML); 1000 UNITS/10ML (100 UNITS/ML) | solution · subcutaneous | NOVO | Prescription | 25 Sep 2015 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | INSULIN DEGLUDEC 100 UNIT/ML VIAL | $11.3401 | per ML | 20 May 2026 |
| US NADAC | TRESIBA 100 UNIT/ML VIAL | $9.02432 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Insulin degludec 100units/ml solution for injection 3ml cartridges | £46.60 | 5 cartridge | 1 Oct 2026 |
| NHS Drug Tariff | Insulin degludec 200units/ml solution for injection 3ml pre-filled disposable devices | £55.92 | 3 pre-filled disposable injection | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 18.5.1. Insulins · core
Therapeutic equivalent to insulin (analogue, long-acting) for Type 2 diabetes mellitus; Therapeutic equivalent to insulin (analogue, long-acting) for Type 1 diabetes mellitus
Safety signals and safety-related labeling changes
- US FDA 14 Oct 2025 XULTOPHY 100/3.6 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 6 Oct 2022 RYZODEG 70/30 — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 1 Jul 2022 TRESIBA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 17 Apr 2020 PRAC signal: Cutaneous amyloidosis
Action for MAH: update of the product information: Yes - EMA PRAC 28 Nov 2019 PRAC signal: Cutaneous amyloidosis
Action for MAH: update of the product information: No - EMA PRAC 30 Nov 2017 PRAC signal: Potential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia
Action for MAH: update of the product information: Yes - EMA PRAC 29 Sep 2017 PRAC signal: Potential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia
Action for MAH: update of the product information: No - EMA PRAC 5 May 2017 PRAC signal: Potential increased risk of medication error associated with pre-filled pens and cartridges presentations, leading to inadequate diabetes control
Action for MAH: update of the product information: Yes - MHRA 11 Dec 2014 Insulin degludec (Tresiba▼): available in additional higher strength
Care needed to minimise risk of error, including training for patients.
Combinations containing Insulin degludec
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.