Beriglobin - supply shortage
Ongoing
human normal immunoglobulin
Shortage
Human
Shortage information
The company for Beriglobin, CSL Behring GmbH, has stopped manufacturing the medicine in the EU/EAA (European Union/European Economic Area). As a result, Beriglobin will no longer be available in the EU/EEA.
Beriglobin is given as an injection into a muscle to protect adults and children against infection caused by the hepatitis A virus. It can be used before and after exposure to the virus.
Beriglobin is also given as an injection under the skin as replacement therapy in adults and children who are at risk of infection because they lack immunoglobulins, a type of protein (called antibodies) in the blood that help the body fight infections. This includes people:
- with primary immunodeficiency syndrome, meaning that they were born with a reduced ability or inability to produce antibodies;
- with chronic lymphocytic leukaemia (a blood cancer) who have hypogammaglobulinaemia (low levels of antibodies) and recurrent bacterial infections, and who cannot be given antibiotics for prevention;
- with multiple myeloma (cancer of the bone marrow) who have hypogammaglobulinaemia and recurrent bacterial infections;
- who are to undergo or have undergone an allogeneic haematopoietic stem cell transplant (when a patient receives stem cells from a donor to help the bone marrow produce healthy blood cells), and who have hypogammaglobulinaemia.
In some countries, Beriglobin is used to treat people with radiation-induced oral mucositis (inflammation and ulceration of the lining of the mouth and throat, usually due to radiotherapy for head and neck cancer).
The active substance in Beriglobin is human normal immunoglobulin, which is a highly purified protein extracted from donated human blood. Beriglobin contains mainly immunoglobulin G (IgG), including antibodies against hepatitis A.
The company for Beriglobin ended production of the medicine in August 2024 and will now permanently stop marketing the medicine. The timelines for discontinuing marketing vary depending on the country where the medicine is marketed.
This will lead to a shortage of Beriglobin, which may be critical for post-exposure prophylaxis against hepatitis A, particularly in vulnerable patients, including immunocompromised people (people with a weakened immune system) and those with chronic liver disease. These people have an increased risk of serious hepatitis A disease and there are no authorised alternatives available to prevent the disease after exposure to the virus. The discontinuation is for commercial reasons and not a consequence of any safety, efficacy or quality related issue.
The shortage affects all Member States where the product is or was authorised, namely Austria, Germany, Spain and Sweden. It will also affect other countries that may import Beriglobin.
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 supply shortage.
The SPOC Working Party Supports EMA’s MSSG and monitors and reports events that could affect the supply of medicines in the EU.
- A medicine shortage communication (MSC) will be sent to relevant healthcare professionals in affected Member States and has also been published on the EMA website.
- The MSC includes recommended measures for healthcare professionals.
- For additional information consult your national shortage register or contact your national competent authority.
- If you have been receiving Beriglobin as replacement therapy because you have no or low levels of antibodies, your doctor will prescribe you an alternative normal human immunoglobulin medicine.
- If you were due to receive Beriglobin to protect you from hepatitis A disease before possible exposure to the virus, you may be given a vaccine instead.
- If you have been exposed to hepatitis A, your doctor will discuss a suitable approach with you, in line with the national guidance in your country.
- If you are receiving Beriglobin to treat radiation-induced mucositis, your doctor will discuss alternative treatments with you.
- 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. A list of European not-for-profit organisations that EMA engages with can be found on the EMA website.
Key facts
- Medicines affected
- Beriglobin
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- human normal immunoglobulin
- Therapeutic area (MESH)
- Primary Immunodeficiency Diseases
- Immunologic Deficiency Syndromes
- Hepatitis A
- Mucositis
- Pharmaceutical forms affected
- Solution for injection in pre-filled syringe
- Strengths affected
- 2 ml and 5 ml (160 mg/ml) solution
- Availability of alternatives
- Depending on indication
Key dates
- First published