Tresiba - supply shortage
Ongoing
insulin degludec
Shortage
Human
Shortage information
Tresiba is used to treat type 1 and type 2 diabetes in adults and children aged 1 to 18 years of age.
There has been a delay in the production of Tresiba at some of the company’s sites. This has led to intermittent supply shortages for Tresiba that are expected to continue until the end of 2023 in some EU Member States.
Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Romania, Spain, and Sweden.
This information may change. For up-to-date information about the status of a medicine shortage in a particular Member State, contact the national competent authority.
EMA’s SPOC working party is closely monitoring the supply situation and engaging with the marketing authorisation holder and other stakeholders to identify measures to mitigate the impact of the supply shortage.
The SPOC working party is responsible for monitoring and reporting events that could affect the supply of medicines in the EU.
- Production capacity limitations have led to intermittent supply shortages that are expected to continue until the end of 2023 in some EU Member States.
- The shortage concerns 100 and 200 units/ml solution for injection in pre-filled pens (FlexTouch). The cartridges of Tresiba solution for injection (3ml of 100 units/ml) remain available.
- Healthcare professionals should ensure that patients at risk of running out of Tresiba are switched to a suitable alternative in time.
- Additional advice may be available from your country’s national shortage register or national competent authority
- Production capacity limitations have led to intermittent supply shortages that are expected to continue until the end of 2023.
- The shortage concerns 100 and 200 units/ml solution for injection in pre-filled pens (FlexTouch). The cartridges of Tresiba solution for injection (3ml of 100 units/ml) remain available.
- If you are at risk of running out of Tresiba, your doctor will discuss with you the need to switch to a suitable alternative.
- If you have any questions, speak to your doctor or pharmacist.
- Additional advice may be available from your country’s national shortage register or national competent authority.
Key facts
- Medicines affected
- Tresiba
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- insulin degludec
- Therapeutic area (MESH)
- Diabetes Mellitus
- Pharmaceutical forms affected
- Pre-filled pen
- Strengths affected
- 100 units/ml
- 200 units/ml
- Availability of alternatives
- Yes
Key dates
- First published