Pegasys - supply shortage
Ongoing
peginterferon alfa-2a
ShortageHuman
Shortage information
Pegasys is a medicine used to treat:
- chronic (long-term) hepatitis B in adults and children from 3 years of age and chronic hepatitis C in adults and children from 5 years of age. Hepatitis B and C are diseases of the liver due to infection with the hepatitis B and C viruses, respectively.
- adults with polycythaemia vera (a disease in which the body produces too many red blood cells, which can cause the blood to thicken and reduce blood flow to the organs) and essential thrombocythaemia (a disease in which there are too many platelets in the blood).
Pegasys is given as an injection under the skin.
An unexpected increase in demand for Pegasys has led to intermittent shortages in the European Union (EU), which are expected to last until the second half of 2025. The shortages are not related to a quality defect of the product or a safety issue.
Intermittent shortages may affect all Member States where the product is marketed. For up-to-date information about the status of a medicine shortage in a particular EU/EEA Member State, consult the national shortage register or contact the national competent authority.
EMA’s SPOC working party is closely monitoring the supply situation and engaging with the marketing authorisation holder 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.
The marketing authorisation holder is opening a new manufacturing site; to avoid further shortages, they recommend that Member States do not stock more Pegasys than is necessary. The active substance available is being prioritised to produce Pegasys 90 mcg vials of solution for injection.
- An unexpected increase in demand for Pegasys has led to intermittent shortages in the European Union (EU), which are expected to last until the second half of 2025.
- No new patients should be started on Pegasys until supply has normalised. Available product should only be used to continue treatment of patients currently treated.
- In case Pegasys is not available for patients currently treated, alternative treatment options should be considered based on your clinical judgement.
- Always store supplies in the fridge and use the most appropriate strength to avoid wastage.
- A direct healthcare professional communication (DHPC) has been sent to healthcare professionals in affected Member States and will also be published.
- For additional information, consult your country’s shortage register or contact your national competent authority.
- An unexpected increase in demand for Pegasys has led to intermittent shortages in the European Union (EU), which are expected to last until the second half of 2025.
- Contact your pharmacy or doctor well before your current supply of Pegasys runs out.
- If Pegasys is not available in your country, your doctor may recommend another suitable medicine.
- If you have any questions, speak to your doctor or pharmacist.
- For additional information, consult your country’s shortage register or contact your national competent authority.
- You may also contact relevant patients’ organisations for further information or support.
Key facts
- Medicines affected
- Pegasys
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- peginterferon alfa-2a
- Therapeutic area (MESH)
- Hepatitis C, Chronic
- Hepatitis B, Chronic
- Polycythemia Vera
- Thrombocythemia, Essential
- Pharmaceutical forms affected
- Solution for injection
- Strengths affected
- 90 mcg
- 135 mcg
- 180 mcg
Key dates
- Expected resolution
- Second half of 2025
- First published