NovoRapid Novo Nordisk A/S · Authorised · authorised 7 Sep 1999 · ATC A10AB05
Therapeutic indication (EMA)
NovoRapid is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Active substance
Insulin aspart
- SFDA 6
- US FDA 8
- EMA 8
- Health Canada 8
- US price lines 6
- NHS prices 4
- WHO EML 1
- Safety 7
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Kirsty | 100 IU/ml | Solution for injection · Subcutaneous use | 5 Pre-filled pen | SAR 141.75 | Biological · Prescription | Biocon SDN BHD | Valid |
| NOVORAPID FLEXPEN 100U\ML | 100 IU/ml | Solution for injection · Subcutaneous use | 5 Pre-filled pen | SAR 189.00 | Biological · Prescription | NOVO NORDISK | Valid |
| NOVORAPID PEN FILL 100 I.U - ML | 100 IU/ml | Solution for injection · Subcutaneous use | 5 Cartridge | SAR 134.90 | Biological · Prescription | NOVO NORDISK | Valid |
| NovoRapid | 100 U/ml | Solution for injection · Intravenous, Subcutaneous | 1 Vial | SAR 81.65 | Biological · Prescription | NOVO NORDISK | Valid |
| Truvelog | 100 IU/ml | Solution for injection · Subcutaneous use | 5 Pre-filled pen | SAR 141.75 | Biological · Prescription | SANOFI AVENTIS GROUPE | Valid |
| NOVORAPID FLEXTOUCH 100U\ML | 100 IU/ml | Solution for injection · Subcutaneous use | 5 Pre-filled pen | SAR 151.20 | Biological · Prescription | NOVO NORDISK | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
DIABETES MELLITUS TYPE 1; DIABETES MELLITUS TYPE 2; DIABETIC KETOACIDOSIS; GESTATIONAL DIABETES
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FIASP | 1000 UNITS/10ML (100 UNITS/ML) | solution · intravenous, subcutaneous | NOVO | Prescription | 29 Sep 2017 |
| FIASP FLEXTOUCH | 300 UNITS/3ML (100 UNITS/ML) | solution · subcutaneous | NOVO | Prescription | 29 Sep 2017 |
| FIASP PENFILL | 300 UNITS/3ML (100 UNITS/ML) | solution · subcutaneous | NOVO | Prescription | 29 Sep 2017 |
| MERILOG | 10ML(100UNITS/ML) | injection · solution | SANOFI-AVENTIS U.S. LLC | Prescription | 14 Feb 2025 |
| MERILOG SOLOSTAR | 3ML(100UNITS/ML) | injection · solution | SANOFI-AVENTIS U.S. LLC | Prescription | 14 Feb 2025 |
| KIRSTY | 100 UNITS/ML | injection · solution | BIOCON BIOLOGICS INC | Prescription | 15 Jul 2025 |
| GARZULYS | 3ML | pen · prefilled | EMERGE BIOSCIENCE PTE. LTD. | Prescription | 24 Jul 2026 |
| GARZULYS | 10ML | vial · multidose | EMERGE BIOSCIENCE PTE. LTD. | Prescription | 24 Jul 2026 |
EMA European Union — centrally authorised medicines
NovoMix Novo Nordisk A/S · Authorised · authorised 1 Aug 2000 · ATC A10AD05
Therapeutic indication (EMA)
Treatment of diabetes mellitus.
Fiasp Novo Nordisk A/S · Authorised · authorised 9 Jan 2017 · ATC A10AB05
Therapeutic indication (EMA)
Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Insulin aspart Sanofi Sanofi Winthrop Industrie · Authorised · authorised 25 Jun 2020 · ATC A10AB05
Therapeutic indication (EMA)
Insulin aspart Sanofi is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Kirsty (previously Kixelle) Biosimilar Collaborations Ireland Limited · Authorised · authorised 5 Feb 2021 · ATC A10AB05
Therapeutic indication (EMA)
Kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Dazparda Gan & Lee Pharmaceuticals Europe GmbH · Authorised · authorised 27 Apr 2026 · ATC A10AB05
Therapeutic indication (EMA)
Dazparda is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Insulin Aspart Injection Masuu Pharma Europe Limited · Application withdrawn · ATC A10AB05
Therapeutic indication (EMA)
Treatment of diabetes mellitus
Truvelog Mix 30 Sanofi Winthrop Industrie · Withdrawn · authorised 25 Apr 2022 · ATC A10AD05
Therapeutic indication (EMA)
Truvelog Mix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| FIASP | 02460408 | 100 UNIT / ML | SOLUTION · SUBCUTANEOUS | NOVO NORDISK CANADA INC |
| FIASP | 02460416 | 100 UNIT / ML | SOLUTION · SUBCUTANEOUS | NOVO NORDISK CANADA INC |
| KIRSTY | 02520974 | 100 UNIT / ML | SOLUTION · SUBCUTANEOUS | BIOCON BIOLOGICS CANADA INC |
| NOVORAPID | 02244353 | 100 UNIT / ML | SOLUTION · SUBCUTANEOUS | NOVO NORDISK CANADA INC |
| NOVORAPID | 02245397 | 100 UNIT / ML | SOLUTION · SUBCUTANEOUS | NOVO NORDISK CANADA INC |
| TRURAPI | 02506564 | 100 UNIT / ML | SOLUTION · SUBCUTANEOUS | SANOFI-AVENTIS CANADA INC |
| TRURAPI | 02506572 | 100 UNIT / ML | SOLUTION · SUBCUTANEOUS | SANOFI-AVENTIS CANADA INC |
| TRURAPI | 02529254 | 100 UNIT / ML | SOLUTION · INTRAVENOUS; SUBCUTANEOUS | SANOFI-AVENTIS CANADA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | FIASP 100 UNIT/ML FLEXTOUCH | $8.9104 | per ML | 23 Sep 2026 |
| US NADAC | FIASP 100 UNIT/ML VIAL | $6.92167 | per ML | 23 Sep 2026 |
| US NADAC | FIASP PENFILL 100 UNIT/ML CART | $8.54568 | per ML | 23 Sep 2026 |
| US NADAC | INSULIN ASPART 100 UNIT/ML VL | $6.95482 | per ML | 20 May 2026 |
| US NADAC | MERILOG 100 UNIT/ML VIAL | $6.81956 | per ML | 23 Sep 2026 |
| US NADAC | MERILOG SOLOSTAR 100 UNIT/ML | $8.7161 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Insulin aspart 100units/ml solution for injection 1.6ml cartridges | £15.10 | 5 cartridge | 1 Oct 2026 |
| NHS Drug Tariff | Insulin aspart 100units/ml solution for injection 10ml vials | £14.08 | 1 vial | 1 Oct 2026 |
| NHS Drug Tariff | Insulin aspart 100units/ml solution for injection 3ml cartridges | £28.31 | 5 cartridge | 1 Oct 2026 |
| NHS Drug Tariff | Insulin aspart 100units/ml solution for injection 3ml pre-filled disposable devices | £30.60 | 5 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, rapid-acting) for Type 1 diabetes mellitus; Therapeutic equivalent to insulin (analogue, rapid-acting) for Type 2 diabetes mellitus
Safety signals and safety-related labeling changes
- US FDA 21 Jun 2023 FIASP — safety-related labeling change
Labeling sections changed: 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 - 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
Combinations containing Insulin aspart
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.