Is Insulin aspart + Insulin degludec registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Insulin aspart + Insulin degludec, including RYZODEG FlexTouch 100 u/ml (70,30 %,%, Solution for injection, SAR 378.90); Ryzodeg FlexPen (100 U/ml, Solution for injection in pre-filled pen, SAR 378.90).

Is Insulin aspart + Insulin degludec approved by the US FDA?

Drugs@FDA lists 1 application product line for Insulin aspart + Insulin degludec, including RYZODEG 70/30 (Discontinued).

Is Insulin aspart + Insulin degludec authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Insulin aspart + Insulin degludec: Ryzodeg.

Active substances

Insulin aspart + Insulin degludec

SFDA 3
US FDA 1
EMA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
RYZODEG FlexTouch 100 u/ml	70,30 %,%	Solution for injection · Subcutaneous use	5 Pre-filled pen	SAR 378.90	NCE · Prescription	NOVO NORDISK	Valid
Ryzodeg FlexPen	100 U/ml	Solution for injection in pre-filled pen · Subcutaneous use	5 Pre-filled pen	SAR 378.90	Biological · Prescription	NOVO NORDISK	Valid
RYZODEG PenFill 100 u/ml	100 IU/ml	Solution for injection · Subcutaneous use	5 Pre-filled pen	SAR 378.90	NCE · Prescription	NOVO NORDISK	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 1; DIABETES MELLITUS TYPE 2

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

Product	Strength	Form · route	Applicant	Status	First approved
RYZODEG 70/30	90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML)	solution · subcutaneous	NOVO	Discontinued	25 Sep 2015

EMA European Union — centrally authorised medicines

Ryzodeg Novo Nordisk A/S · Authorised · authorised 21 Jan 2013 · ATC A10AD06

Therapeutic indication (EMA)

Treatment of diabetes mellitus in adults, adolescents and children from the age of 2 years.

Components

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.