Immune system health

New drugs

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CuvitruB

Medical ingredient:

Immune Globulin (Human)

Indication:

Cuvitru is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection. Cuvitru is used to treat patients with primary immunodeficiency diseases (PI) and with secondary humoral immunodeficiency diseases (SI).

For more information, see the Regulatory Decision Summary.

Flebogamma 5%B, Flebogamma 10%B

Medical ingredient:

Immune Globulin (Human)

Indication:

Flebogamma is indicated for replacement therapy in adults, children and adolescents (2-18 years) in:

  • patients with Primary Immunodeficiency (PID), an inborn lack of antibodies
  • hypogammaglobulinaemia (a condition implying low immunoglobulin levels in your blood) and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (cancer of the blood where too many white blood cells are produced), in whom prophylactic antibiotics have failed
  • hypogammaglobulinaemia (a condition implying low immunoglobulin levels in your blood) and recurrent bacterial infections in myeloma (tumour composed of cells derived from the bone marrow) patients who failed to respond to pneumococcal immunisation
  • hypogammaglobulinaemia (a condition implying low immunoglobulin levels in your blood) in patients after a stem cell transplantation (allogeneic haematopoietic stem cells transplantation), when you are given stem cells from another person
  • children and adolescents with the Acquired Immune Deficiency Syndrome (AIDS), it can be used to prevent troublesome infections

Treatment of certain autoimmune disorders (immunomodulation) in adults, children and adolescents (2 - 18 years):

  • primary immune thrombocytopenia (ITP), a condition where the number of platelets in the blood stream is greatly reduced. Platelets form an important part of the clotting process and a reduction in their numbers may cause unwanted bleeding and bruising. The product is also used in patients at high risk of bleeding or prior to surgery to correct the platelet count
  • Guillain Barré syndrome, where the immune system damages the nerves and hinders them from working properly

For more information, see the Regulatory Decision Summary.

Odefsey

Medical ingredient:

Emtricitabine, Rilpivirine Hydrochloride, Tenofovir Alafenamide Fumarate

Indication:

Odefsey is used to treat people with Human Immunodeficiency Virus (HIV) infection. Odefsey is for adults.

For more information, see the Regulatory Decision Summary.

PrevymisP,O

(new active substance)

Medical ingredient:

Letermovir

Indication:

Prevymis is a medicine to help to keep adults 18 years of age and older from getting ill from CMV (cytomegalovirus).

For more information, see the Regulatory Decision Summary.

New generic drugs

Health Canada approved 21 new generic drugs for immune system health.

Risk communications

Health Canada released seven risk communications on immune system health.

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