Insuman Rapid, Basal and Comb 25 (insulin human) - supply shortage
Ongoing
insulin human
ShortageHuman
Shortage information
Insuman is used in patients with diabetes (type 1 and 2) who need treatment with insulin.
Insuman Rapid can also be used for the treatment of hyperglycaemic coma (coma caused by too much blood glucose [sugar]) and ketoacidosis (high levels of ketones [acids] in the blood), and to control blood glucose before, during or after an operation.
Several events at the manufacturing site resulted in a temporary supply shortage of Insuman in early 2023. They included supply delays of pen components and issues on filling, assembly and packaging lines. In addition, the marketing authorisation holder has decided to stop production and marketing of Insuman Rapid, Basal and Comb 25 worldwide.
All EU Member States where Insuman Rapid, Basal and Comb 25 are currently authorised.
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.
- There have been supply shortages of Insuman Basal, Rapid and Comb 25 since January 2023. In addition, the marketing authorisation holder has decided to stop production and marketing of Insuman Rapid, Basal and Comb 25 worldwide.
- As a result, no new patients should be started with any of the impacted Insuman products and existing patients should be switched to suitable alternatives at the next scheduled appointment.
- Alternatives should be chosen based on national or local guidance and based on the patients’ needs. The switch should be done under the supervision of a healthcare professional with close monitoring of blood glucose levels.
- A delay in switching may result in patients missing the required doses, which may have serious clinical consequences such as hyperglycaemia.
- A direct healthcare professional communication (DHPC) has been sent to relevant healthcare professionals.
- Additional advice may be available from your country’s national shortage register.
- There have been supply shortages of Insuman Basal, Rapid and Comb 25 since January 2023. In addition, the marketing authorisation holder has decided to stop production and marketing of Insuman Rapid, Basal and Comb 25 worldwide. If you take Insuman Basal, Rapid and Comb 25, make an appointment with your doctor before your current insulin supply finishes, so that a suitable alternative can be found.
- A delay in switching may result in you missing doses, which may lead to high blood sugar levels.
- Switching to an alternative medicine should be done under the supervision of a healthcare professional and with close monitoring of blood sugar levels.
- If you have any questions, speak to your doctor or pharmacist.
- Additional advice may be available from your country’s national shortage register.
Key facts
- Medicines affected
- Insuman Rapid, Basal and Comb 25 (insulin human)
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- insulin human
- Therapeutic area (MESH)
- Diabetes Mellitus
- Pharmaceutical forms affected
- Solution for injection
- Pre-filled pen
- Strengths affected
- 3 ml
Key dates
- First published
- Last updated