Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 28 August 2018

Indication(s)

Replacement therapy in adults, children and adolescents (0-18 years) in:
- Primary immunodeficiency syndromes with impaired antibody production.
- Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated.
- Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients.
- Hypogammaglobulinaemia in patients pre- and post-allogeneic hematopoietic stem cell transplantation (HSCT).

Full Prescribing information

Learning Zones

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Chronic Lymphocytic Leukaemia (CLL)

Chronic Lymphocytic Leukaemia (CLL)

Refine your knowledge of chronic lymphocytic leukaemia (CLL) with information on pathophysiology, diagnosis, treatment options and more

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Transplantation

Transplantation

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Biosimilars Knowledge Centre

Biosimilars Knowledge Centre

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More information

Category Value
Agency product number EMEA/H/C/002491
Orphan designation No
Date First Approved 16-05-2013
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Baxalta Innovations GmbH
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions