Active substance
Insulin detemir recombinant
- US FDA 5
- Safety 5
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| LEVEMIR | 1000 UNITS/10ML (100 UNITS/ML) | injectable · subcutaneous | NOVO NORDISK INC | Prescription | 16 Jun 2005 |
| LEVEMIR FLEXTOUCH | 300 UNITS/3ML (100 UNITS/ML) | injectable · subcutaneous | NOVO NORDISK INC | Prescription | 16 Jun 2005 |
| LEVEMIR FLEXPEN | 300 UNITS/3ML (100 UNITS/ML) | injectable · subcutaneous | NOVO NORDISK INC | Discontinued | 16 Jun 2005 |
| LEVEMIR INNOLET | 300 UNITS/3ML (100 UNITS/ML) | injectable · subcutaneous | NOVO NORDISK INC | Discontinued | 16 Jun 2005 |
| LEVEMIR PENFILL | 300 UNITS/3ML (100 UNITS/ML) | injectable · subcutaneous | NOVO NORDISK INC | Discontinued | 16 Jun 2005 |
Safety signals and safety-related labeling changes
- US FDA 8 Dec 2022 LEVEMIR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 8 Dec 2022 LEVEMIR FLEXPEN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 8 Dec 2022 LEVEMIR FLEXTOUCH — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 8 Dec 2022 LEVEMIR INNOLET — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 8 Dec 2022 LEVEMIR PENFILL — safety-related labeling change
Labeling sections changed: Contraindications; 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.