NovoSeven (eptacog alfa) - supply shortage
Ongoing
eptacog alfa (activated)
ShortageHuman
Shortage information
Intermittent shortages and limited availability of NovoSeven have occurred in some EU countries; availability issues may continue throughout 2025. To mitigate the impact of intermittent shortages and potential limited availability across the EU, packs of NovoSeven with labelling and product information in English may be distributed in some countries where English is not the official language, in agreement with national medicine agencies.
NovoSeven is a medicine used to treat bleeding episodes and to prevent bleeding after surgical procedures. It is used in patients with:
- congenital haemophilia (a bleeding disorder present from birth) who have developed or are expected to develop ‘inhibitors’ (antibodies) against factor VIII or IX;
- acquired haemophilia (a bleeding disease caused by the development of inhibitors to factor VIII);
- congenital factor VII deficiency;
- Glanzmann’s thrombasthenia (a rare bleeding disorder), who cannot be treated with a transfusion of platelets (components that help the blood to clot);
NovoSeven is also used to treat severe postpartum haemorrhage (serious bleeding after giving birth), when medicines that stimulate the muscles of the womb to contract (uterotonic medicines) are not effective at controlling the bleeding.
NovoSeven contains the active substance eptacog alfa.
For further information on the use of NovoSeven please refer to the medicine’s overview page.
The availability problems are due to capacity constraints and issues during the packaging process of NovoSeven.
For up-to-date information about the availability of NovoSeven, including which doses are affected and the availability of English-language packs in a particular EU/EEA Member State, consult the national shortage register or contact the national competent authority.
EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and 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 to mitigate the impact of the supply shortage.
- Intermittent shortages and limited availability of NovoSeven have occurred in some EU countries; availability issues may continue throughout 2025.
- To mitigate the impact of intermittent shortages and potential limited availability, packs of NovoSeven with labelling and product information in English may be distributed in EU countries where English is not the official language.
- If this is not sufficient and NovoSeven becomes unavailable, healthcare professionals should ensure that patients using NovoSeven are safely switched to an alternative strength or to suitable alternatives, if appropriate, based on their clinical judgment and according to local recommendations.
- For additional information consult your country’s shortage register or contact your national competent authority.
- Intermittent shortages and limited availability of NovoSeven have occurred in some EU countries; availability issues may continue throughout 2025.
- When you receive NovoSeven, it may be accompanied by information in English (on the box and package leaflet). If you need help understanding the information or have any other questions, speak to your doctor or pharmacist.
- If NovoSeven is not available, your doctor may prescribe a different medicine.
- For additional information about the supply of NovoSeven, consult your country’s shortage register or contact your national competent authority.
Key facts
- Medicines affected
- NovoSeven (eptacog alfa)
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- eptacog alfa (activated)
- Pharmaceutical forms affected
- Powder and solvent for solution for injection
- Strengths affected
- 1, 2, 5 and 8 mg (50, 100, 250 and 400 KIU)
- Availability of alternatives
- Unknown
Key dates
- Expected resolution
- First published
- Last updated