Active substance
Insulin lispro recombinant
- US FDA 5
- Safety 8
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| HUMALOG | 100 UNITS/ML | injectable · injection | LILLY | Prescription | 14 Jun 1996 |
| HUMALOG KWIKPEN | 100 UNITS/ML; 200UNITS/ML | injectable · injection | LILLY | Prescription | 14 Jun 1996 |
| HUMALOG TEMPO PEN | 100UNITS/ML | injectable · injection | LILLY | Prescription | 14 Jun 1996 |
| HUMALOG KWIKPEN | 200 UNITS/ML | solution · subcutaneous | ELI LILLY AND CO | Prescription | 26 May 2015 |
| HUMALOG PEN | 100 UNITS/ML | injectable · injection | LILLY | Discontinued | 14 Jun 1996 |
Safety signals and safety-related labeling changes
- US FDA 7 May 2025 HUMALOG — 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 7 May 2025 HUMALOG KWIKPEN — 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 21 Jul 2023 HUMALOG MIX 50/50 — 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 21 Jul 2023 HUMALOG MIX 50/50 KWIKPEN — 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 21 Jul 2023 HUMALOG MIX 50/50 PEN — 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 21 Jul 2023 HUMALOG MIX 75/25 — 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 21 Jul 2023 HUMALOG MIX 75/25 KWIKPEN — 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 21 Jul 2023 HUMALOG MIX 75/25 PEN — 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
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.