Regulatory PathRegulatory requirements compared

Active substance

Insulin human

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
HUMULIN-R-REGULAR 100 U-ML100 IU/mlSolution for injection · Subcutaneous use1 VialSAR 53.55Biological · PrescriptionEli Lilly and CompanyValid
INSULATARD100 IU/mlSuspension for injection · Subcutaneous use1 VialSAR 65.00Biological · PrescriptionNOVO NORDISKValid
HUMULIN-L LENTE 100 U-ML100 IU/mlSuspension for injection · Subcutaneous use1 VialSAR 53.55Biological · OTCEli Lilly and CompanyWithdrawn by MAH · Not Marketed
HUMULIN-R 100U-ML CARTRIDGE100 IU/mlSolution for injection · Subcutaneous use5 CartridgeSAR 93.70Biological · PrescriptionEli Lilly and CompanyWithdrawn by MAH · Not Marketed
ULTRATARD HM 100 I.U. VIAL100 IU/mlSuspension for injection · Subcutaneous use1 VialSAR 65.00Biological · PrescriptionNOVO NORDISKWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

BRADYCARDIA; DIABETES MELLITUS TYPE 1; DIABETES MELLITUS TYPE 2; DIABETIC KETOACIDOSIS; HYPERKALEMIA

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
HUMULIN R KWIKPEN1500 UNITS/3ML (500 UNITS/ML)solution · subcutaneousLILLYPrescription28 Oct 1982
HUMULIN R10000 UNITS/20ML (500 UNITS/ML)solution · subcutaneousLILLYPrescription28 Oct 1982
MYXREDLIN100 UNITS/100ML (1 UNIT/ML)solution · intravenousBAXTER HLTHCARE CORPPrescription20 Jun 2019

EMA European Union — centrally authorised medicines

Insuman Sanofi-aventis Deutschland GmbH · Authorised · authorised 21 Feb 1997 · ATC A10AB01;A10AC01

Therapeutic indication (EMA)

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.

Actrapid Novo Nordisk A/S · Authorised · authorised 7 Oct 2002 · ATC A10AB01

Therapeutic indication (EMA)

Treatment of diabetes mellitus.

Actraphane Novo Nordisk A/S · Authorised · authorised 7 Oct 2002 · ATC A10AD01

Therapeutic indication (EMA)

Treatment of diabetes mellitus.

Mixtard Novo Nordisk A/S · Authorised · authorised 7 Oct 2002 · ATC A10AD01

Therapeutic indication (EMA)

Treatment of diabetes mellitus.

Insulatard Novo Nordisk A/S · Authorised · authorised 7 Oct 2002 · ATC A10AC01

Therapeutic indication (EMA)

Treatment of diabetes mellitus.

Protaphane Novo Nordisk A/S · Authorised · authorised 7 Oct 2002 · ATC A10AC01

Therapeutic indication (EMA)

Treatment of diabetes mellitus.

Solumarv Marvel Life Sciences Ltd. · Application withdrawn

Therapeutic indication (EMA)

treatment of diabetes mellitus

Combimarv Marvel Life Sciences Ltd. · Application withdrawn

Therapeutic indication (EMA)

Treatment of diabetes mellitus

Isomarv medium Marvel Life Sciences Ltd. · Application withdrawn

Therapeutic indication (EMA)

treatment of diabetes mellitus

Solumarv Marvel Lifesciences Ltd · Refused · ATC A10AB01

Therapeutic indication (EMA)

Treatment of diabetes

Insulin Human Rechon Rechon Life Science AB · Application withdrawn · ATC A10AB01

Therapeutic indication (EMA)

Treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis

Velosulin Novo Nordisk A/S · Withdrawn · authorised 7 Oct 2002 · ATC A10AB01

Therapeutic indication (EMA)

Treatment of diabetes mellitus.

Ultratard Novo Nordisk A/S · Withdrawn · authorised 7 Oct 2002 · ATC A10AE01

Therapeutic indication (EMA)

Treatment of diabetes mellitus.

Monotard Novo Nordisk A/S · Withdrawn · authorised 7 Oct 2002 · ATC A10AC01

Therapeutic indication (EMA)

Treatment of diabetes mellitus.

Exubera Pfizer Limited · Withdrawn · authorised 24 Jan 2006 · ATC A10AF01

Therapeutic indication (EMA)

EXUBERA is indicated for the treatment of adult patients with type 2 diabetes mellitus notadequately controlled with oral antidiabetic agents and requiring insulin therapy.EXUBERA is also indicated for the treatment of adult patients with type 1 diabetes mellitus, inaddition to long or intermediate acting subcutaneous insulin, for whom the potential benefits ofadding inhaled insulin outweigh the potential safety concerns (see section 4.4).

Insulin Human Winthrop sanofi-aventis Deutschland GmbH · Withdrawn · authorised 17 Jan 2007 · ATC A10AB01

Therapeutic indication (EMA)

Diabetes mellitus where treatment with insulin is required. Insulin Human Winthrop 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.

Inpremzia Baxter Holding B.V. · Withdrawn · authorised 25 Apr 2022 · ATC A10AB01

Therapeutic indication (EMA)

Inpremzia is indicated for the treatment of diabetes mellitus.

Safety signals and safety-related labeling changes

All safety entries for insulin human →

Combinations containing Insulin human

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.