Anpheros Search · Treatment

Insulin human

Also known as: insulin human (rdna) · human insulin (rdna) · Insuman · Actraphane · Mixtard · Insulatard · Protaphane · Actrapid · AFREZZA · HUMULIN R

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In short

In the European Union, insulin human is indicated for the treatment of diabetes mellitus, including cases where insulin treatment is required. Specific formulations in the European Union are also suitable for treating hyperglycaemic coma and ketoacidosis, and for achieving pre-, intra-, and postoperative stabilisation in patients with diabetes mellitus. In the United States, a concentrated formulation is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day. The safety and efficacy of this concentrated formulation have not been determined when used in combination with other insulins or when delivered by continuous subcutaneous infusion.

From: Source: European Medicines Agency (EMA), Actraphane — EPAR, 02/02/2024. © European Medicines Agency. · Source: European Medicines Agency (EMA), Insuman — EPAR, 05/03/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
253182 insulin, regular, human
EMA
EMEA/H/C/000201, EMEA/H/C/000427, EMEA/H/C/000428, EMEA/H/C/000441, EMEA/H/C/000442, EMEA/H/C/000424

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Actraphane

Treatment of diabetes mellitus.

Source: European Medicines Agency (EMA), Actraphane — EPAR, 02/02/2024. © European Medicines Agency.

Document date: 02/02/2024 · Official document →

EMA (EU) Actrapid

Treatment of diabetes mellitus.

Source: European Medicines Agency (EMA), Actrapid — EPAR, 21/10/2020. © European Medicines Agency.

Document date: 21/10/2020 · Official document →

FDA (USA) Humulin R U-500 KwikPen

1 INDICATIONS AND USAGE HUMULIN R U-500 is a concentrated human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day. HUMULIN ® R U-500 is a concentrated human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day. ( 1 ) Limitation of Use: The safety and efficacy of HUMULIN R U-500 used in combination with other insulins has not been determined. The safety and efficacy of HUMULIN R U-500 delivered by continuous subcutaneous infusion has not been determined. ( 1.1 ) 1.1 Limitation of Use The safety and efficacy of HUMULIN R U-500 used in combination with other insulins has not been determined. The safety and efficacy of HUMULIN R U-500 delivered by continuous subcutaneous infusion has not been determined.

Data provided by the U.S. Food and Drug Administration.

Document date: 20260701 · Official document →

EMA (EU) Insulatard

Treatment of diabetes mellitus.

Source: European Medicines Agency (EMA), Insulatard — EPAR, 23/11/2020. © European Medicines Agency.

Document date: 23/11/2020 · Official document →

EMA (EU) Insuman

Diabetes mellitus where treatment with insulin is required. Insuman Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.

Source: European Medicines Agency (EMA), Insuman — EPAR, 05/03/2026. © European Medicines Agency.

Document date: 05/03/2026 · Official document →

EMA (EU) Mixtard

Treatment of diabetes mellitus.

Source: European Medicines Agency (EMA), Mixtard — EPAR, 24/01/2024. © European Medicines Agency.

Document date: 24/01/2024 · Official document →

EMA (EU) Protaphane

Treatment of diabetes mellitus.

Source: European Medicines Agency (EMA), Protaphane — EPAR, 27/10/2020. © European Medicines Agency.

Document date: 27/10/2020 · Official document →

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External resources

Questions

What is Insulin human approved for in the European Union?

Treatment of diabetes mellitus. (Source: European Medicines Agency (EMA), Actraphane — EPAR, 02/02/2024. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Data provided by the U.S. Food and Drug Administration.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Actraphane — EPAR, 02/02/2024. © European Medicines Agency.
  • Source: European Medicines Agency (EMA), Actrapid — EPAR, 21/10/2020. © European Medicines Agency.
  • Source: European Medicines Agency (EMA), Insulatard — EPAR, 23/11/2020. © European Medicines Agency.
  • Source: European Medicines Agency (EMA), Insuman — EPAR, 05/03/2026. © European Medicines Agency.
  • Source: European Medicines Agency (EMA), Mixtard — EPAR, 24/01/2024. © European Medicines Agency.
  • Source: European Medicines Agency (EMA), Protaphane — EPAR, 27/10/2020. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →