Insulin (human insulin) (various short-, rapid-, intermediate-, mixed- and long-acting forms) - supply shortage
Ongoing
Shortage
Human
Shortage information
The company Novo Nordisk has decided to stop marketing some of selected presentations of insulins due to commercial reasons:
- short- and rapid-acting (bolus/mealtime) insulins (human insulin, 100 units/ml, solution for injection),
- intermediate-acting (isophane) insulins (NPH human insulin, 100 units/ml, solution for injection),
- mixed-acting (biphasic) insulins (suspension for injection) and
- long-acting (basal) insulins (solution for injection in pre-filled pen).
These insulins will be discontinued in all Member states where they were previously marketed and will therefore be unavailable.
The table below provides further details on the insulins that are being discontinued.
The listed products/ presentations are not marketed in all EU/EEA countries. However, where they are marketed they will be discontinued.
For more details and up-to-date information, consult your country’s shortage register or contact your national competent authority.
For information on the use of the medicines please refer to the respective medicine overview pages on EMA’s website.
Products |
Presentation(s) subject to discontinuation |
| Short- and rapid-acting insulins | |
| Actrapid (regular human insulin, 100 units/ml, solution for injection) |
Penfill Flexpen Innolet |
| Fiasp (fast-acting insulin aspart, 100 units/ml, solution for injection) | Pumpcart |
| Intermediate-acting insulins | |
| Insulatard (insulin NPH, 100 units/ml, suspension for injection in cartridge) |
Penfill Flexpen Innolet |
| Protaphane (isophane/NPH human insulin, 100 units/ml, suspension for injection in cartridge) |
Penfill Flexpen |
| Mixed-acting (biphasic) insulins | |
| Mixtard 30 (30% soluble insulin and 70% isophane insulin, 100 units/ml, suspension for injection in cartridge or pre-filled pen) |
Penfill Flexpen Innolet |
| Mixtard 50 (50% soluble insulin and 50% isophane insulin, 100 units/ml, suspension for injection in cartridge or pre-filled pen) | Penfill |
| Actraphane 30 (30% soluble insulin and 70% isophane insulin, 100 units/ml, suspension for injection in cartridge or pre-filled pen) |
Penfill Flexpen |
| Actraphane 50 (50% soluble insulin and 50% isophane insulin, 100 units/ml, suspension for injection in cartridge or pre-filled pen) |
Penfill Flexpen |
| NovoMix 50 (50% insulin aspart and 50% insulin aspart protamine 100 units/ml, suspension for injection in cartridge or pre-filled pen) |
Penfill Flexpen |
| Long-acting insulins | |
| Levemir (insulin detemir 100 units/ml, solution for injection, in cartridge or pre-filled pen) |
Penfill Flexpen Innolet Flextouch |
The company Novo Nordisk has decided to stop marketing some of its insulins for commercial reasons. This decision is not related to a quality defect or safety issue.
The timeline for the discontinuation varies between Member States and discontinuation will take effect before the end of 2026. After this date the listed insulins will no longer be available.
All Member States where the listed presentations were marketed are affected by the discontinuations and the presentations will no longer be available. In addition, there may be intermittent shortages in some Member States before the discontinuation.
For more details, consult your country’s shortage register or contact your national competent authority.
EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party) are closely monitoring the supply situation and engaging with the marketing authorisation holder and other stakeholders to mitigate the impact of the planned discontinuations.
The SPOC Working Party Supports EMA’s MSSG and monitors and reports events that could affect the supply of medicines in the EU.
- In the affected Member States healthcare professionals will receive a letter (medicine shortage communication) to provide details and recommendations.
- No new patients should be started on any of the above listed insulins.
- Healthcare professionals should switch any patients who are currently on any of the above listed insulins to alternative insulins based on existing guidance and clinical judgment.
- Healthcare professionals should ensure that all patients are counselled on any changes in the new insulin regimen including the need to change dose and/or usage of the new insulin delivery system and additional glucose monitoring.
- Close glucose monitoring is recommended when the patient is switched to another type or brand of insulin and in the initial weeks thereafter, especially in pregnant women and children who may need closer monitoring than the general population. The risk of hypoglycaemia may be higher in these populations.
- A medicine shortage communication (MSC) has been sent to healthcare professionals in affected Member States and will also be published on the EMA website.
- You may also contact relevant healthcare professional organisations for further information. A list of European not-for-profit organisations EMA engages with can be found on the EMA website.
- For additional information, consult your country’s shortage register or contact your national competent authority.
- Contact your healthcare professional before your current supply of insulin runs out.
- Your healthcare professional will advise you if any of the insulins you are using are affected by the discontinuation and will switch you to an alternative insulin, if needed.
- In case your healthcare professional switches your insulin they will explain any changes to you and ensure that you are given adequate training on using any new insulin delivery system.
- In case you are being switched you may need to closely monitor your glucose levels during the transfer to another type or brand of insulin and in the initial weeks thereafter. This applies especially if you are pregnant or under 18 years of age in which case you are at a higher risk of hypoglycaemia.
- If you have any questions, speak to your doctor or pharmacist.
- You may also contact relevant patients’ organisations for further information or support. A list of European not-for-profit organisations that EMA engages with can be found on the EMA website.
- For additional information, consult your country’s shortage register or contact your national competent authority.
Key facts
- Medicines affected
- Insulin (human insulin) (various short-, rapid-, intermediate-, mixed- and long-acting forms)
- Supply shortage status
- Ongoing
- Pharmaceutical forms affected
- Solution for injection
- Suspension for injection
- Strengths affected
- 100 units/ml
- Availability of alternatives
- Yes
Key dates
- Expected resolution
- End of 2026
- First published