Privigen
Authorised
This medicine is authorised for use in the European Union
human normal immunoglobulin (IVIg)
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Privigen is a medicine used to treat people who:
are at risk of infection because they do not have enough antibodies, particularly immunoglobulin G (IgG). Antibodies are protein in the blood that helps the body fight infections. This includes:
people who are born with a lack of antibodies (primary immunodeficiency syndrome, PID);
people who develop a lack of antibodies after birth (secondary immunodeficiency syndrome, SID), who have low levels of IgG and suffer from infections that are severe or keep coming back despite treatment with medicines used to treat infections.
have certain immune diseases caused by the body’s own immune system attacking normal tissues. In these diseases, Privigen helps regulate the activity of the immune system (immunomodulation). These include:
primary immune thrombocytopenia (ITP), where people do not have enough platelets (components that help the blood to clot) and are at high risk of bleeding;
Guillain-Barré syndrome or chronic inflammatory demyelinating polyneuropathy (CIDP), inflammatory disorders of the nerves that cause muscle weakness and numbness;
Kawasaki disease, a disease mainly seen in children which causes inflammation of blood vessels;
multifocal motor neuropathy, a nerve disorder that causes weakness of the arms and legs.
need protection against measles before or after exposure because they are at risk and cannot receive, or should not receive, measles vaccination.
The medicine contains the active substance human normal immunoglobulin.
Privigen can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating people with immune system disorders.
The medicine is given by infusion (drip) into a vein. How often it is given depends on the disease being treated and the patient’s bodyweight. For the treatment of Kawasaki disease, Privigen should be given together with aspirin (acetylsalicylic acid).
For more information about using Privigen, see the package leaflet or contact your doctor or pharmacist.
Privigen contains the active substance human normal immunoglobulin, which consists of antibodies extracted and purified from the plasma (the liquid part of blood) of healthy people. In people with primary or secondary immunodeficiency, Privigen provides the IgG they lack, reducing their risk of infection. At higher doses, Privigen helps regulate the activity of the immune system in people with autoimmune disorders. In people susceptible to measles, Privigen provides antibodies against the measles virus that help prevent infection and its complications.
As human normal immunoglobulin has been used to treat people with immunodeficiency syndrome and immune disorders for a long time, three small studies were sufficient to establish the effectiveness and safety of Privigen. Privigen was not compared with placebo (a dummy treatment) or other treatments in these studies.
Primary immunodeficiency syndrome
In the first study, Privigen was used in 80 patients with PID, with the medicine being given every three or four weeks. The main measure of effectiveness was the number of serious bacterial infections that occurred over one year of treatment. Patients had an average of 0.08 serious infections per year. Since this is below the predefined threshold of one serious infection per year, this indicates that Privigen is effective as replacement therapy.
Immunomodulation
In the second study, Privigen was used in 57 patients with ITP on two consecutive days. The main measure of effectiveness was the highest blood platelet level that was achieved in the week after treatment. In this study, 81% of patients (46 out of 57) had a platelet count above a safe threshold of 50 million platelets per millilitre of blood at least once during the study. These results showed that Privigen is effective in immunomodulation.
A third study evaluated Privigen in 28 patients with CIDP who were given Privigen every three weeks for 24 weeks. The main measure of effectiveness was the number of patients who showed improvement of their disability, measured by a decrease on a 10-point scale of disability in their arms and legs. In this study, 61% of patients (17 out of 28) responded to treatment with an improvement of at least one point on the disability scale. The average improvement was about 1.4 points.
Prevention of measles disease
Antibodies against measles contained in human normal immunoglobulin medicines have long been known to prevent measles infection and reduce the risk of complications in people at risk of severe disease, particularly when given soon after exposure to the virus. This is supported by studies published in the medical literature on the use of these medicines.
Studies carried out with Privigen are described in more detail in the medicine’s assessment reports.
For the full list of side effects and restrictions with Privigen, see the package leaflet.
The most common side effects with Privigen (which may affect more than 1 in 10 people) include headache, pain (including in the back, neck, arms and legs, joints and face), fever, chills and a flu-like illness.
Some side effects are more likely to occur with a high rate of infusion, in patients with low immunoglobulin levels, or in patients who have not received human normal immunoglobulin before or for a long time.
Privigen must not be used in patients who have deficiency (very low levels) of immunoglobulin A (IgA) and who have antibodies against IgA. This is because it could cause a severe allergic reaction (anaphylaxis) in these patients. Privigen must also not be used in patients with hyperprolinaemia type I or II (a genetic disorder causing high levels of the amino acid proline in the blood).
Privigen was shown to reduce the risk of infection in patients with PID and to improve symptoms of ITP and CIDP. Based on these results, Privigen is also expected to alleviate symptoms of Guillain-Barré syndrome, Kawasaki disease and multifocal motor neuropathy.
The use of human normal immunoglobulin medicines such as Privigen to help prevent measles in people at risk of severe disease is well established. Published studies have shown that these medicines can provide protection against measles. Privigen is therefore expected to be effective in preventing measles infection.
Medicines containing human normal immunoglobulin have been used in the EU since the 1980s. Privigen’s side effects are similar to those of other medicines in the same class; they are mostly mild to moderate and temporary. Severe side effects may occur rarely with Privigen, including severe allergic reactions.
The European Medicines Agency therefore decided that Privigen’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Privigen have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Privigen are continuously monitored. Side effects reported with Privigen are carefully evaluated and any necessary action taken to protect patients.
Privigen received a marketing authorisation valid throughout the EU on 25 April 2008.
Product information
Latest procedure affecting product information:VR/0000304719
26/05/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Privigen
- Active substance
- human normal immunoglobulin (IVIg)
- International non-proprietary name (INN) or common name
- human normal immunoglobulin (IVIg)
- Therapeutic area (MeSH)
- Purpura, Thrombocytopenic, Idiopathic
- Bone Marrow Transplantation
- Immunologic Deficiency Syndromes
- Guillain-Barre Syndrome
- Mucocutaneous Lymph Node Syndrome
- Anatomical therapeutic chemical (ATC) code
- J06BA02
Pharmacotherapeutic group
Immune sera and immunoglobulinsTherapeutic indication
Replacement therapy in adults, and children and adolescents (0-18 years) in:
- primary immunodeficiency (PID) syndromes with impaired antibody production;
- hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed;
- hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who have failed to respond to pneumococcal immunisation;
- hypogammaglobulinaemia in patients after allogeneic haematopoietic-stem-cell transplantation (HSCT);
- congenital AIDS with recurrent bacterial infections.
Immunomodulation in adults, and children and adolescents (0-18 years) in:
- primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count;
- Guillain-Barré syndrome;
- Kawasaki disease;
- chronic inflammatory demyelinating polyneuropathy (CIDP). Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.
Assessment history
News on Privigen
Θέματα
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