Is Insulin detemir registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Insulin detemir, including LEVEMIR FLEX PEN 100IU\ML (100 IU/ml, Solution for injection, SAR 262.55).

Is Insulin detemir approved by the US FDA?

Drugs@FDA lists 1 application product line for Insulin detemir, including LEVEMIR (Prescription).

Is Insulin detemir authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Insulin detemir: Levemir.

Is Insulin detemir on the WHO Model List of Essential Medicines?

Yes — 18.5.1. Insulins (core list): Therapeutic equivalent to insulin (analogue, long-acting) for Type 2 diabetes mellitus; Therapeutic equivalent to insulin (analogue, long-acting) for Type 1 diabetes mellitus.

Are there safety signals or safety updates for Insulin detemir?

EMA PRAC: 3 entries (latest 2017-11-30).

Active substance

Insulin detemir

SFDA 1
US FDA 1
EMA 1
NHS prices 2
WHO EML 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
LEVEMIR FLEX PEN 100IU\ML	100 IU/ml	Solution for injection · Subcutaneous use	5 Pre-filled pen	SAR 262.55	Biological · Prescription	NOVO NORDISK	Valid

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 1; DIABETES MELLITUS TYPE 2; GESTATIONAL DIABETES

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

Product	Strength	Form · route	Applicant	Status	First approved
LEVEMIR	100 UNITS/ML	injectable · injection	NOVO NORDISK	Prescription	19 Oct 2005

EMA European Union — centrally authorised medicines

Levemir Novo Nordisk A/S · Authorised · authorised 1 Jun 2004 · ATC A10AE05

Therapeutic indication (EMA)

Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Insulin detemir 100units/ml solution for injection 3ml cartridges	£42.00	5 cartridge	1 Oct 2026
NHS Drug Tariff	Insulin detemir 100units/ml solution for injection 3ml pre-filled disposable devices	£42.00	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, long-acting) for Type 2 diabetes mellitus; Therapeutic equivalent to insulin (analogue, long-acting) for Type 1 diabetes mellitus

Safety signals and safety-related labeling changes

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

All safety entries for insulin detemir →

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.