On 15 March 2010 the European Commission granted a marketing authorisation for the whole European Union to Cangene Europe Limited for ImmunoGam (Human Hepatitis B Immunoglobulin). ImmunoGam (Human Hepatitis B Immunoglobulin) is a solution for injection that contains the active substance human hepatitis B immunoglobulin. ImmunoGam was indicated for the prevention of hepatitis B virus recurrence after liver transplantation in HBsAg\-positive patients and immunoprophylaxis of hepatitis B. On 17 August 2010, the marketing authorisation holder (MAH) responsible for ImmunoGam has requested the voluntary withdrawal of ImmuoGam from the Community Register. The European Commission adopted the decision to withdraw, at the holder’s request, the marketing authorisation granted by Decision C(2010\)1810 for ImmunoGam (Human Hepatitis B Immunoglobulin) on 6 September 2010\.
Therapeutic Indication
Immunoprophylaxis of Hepatitis B \- In case of accidental exposure in non\-immunised subjects (including persons whose vaccination is incomplete or status unknown). \- In haemodialysed patients, until vaccination has become effective. \- In the newborn of a hepatitis B virus carrier\-mother. \- In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B. Consideration should also be given to other official guidance on the appropriate use of human hepatitis B immunoglobulin for intramuscular use.
Therapeutic Area (MeSH)
ATC Code
J06BB04
ATC Item
N/A
Pharmacotherapeutic Group
Specific immunoglobulins
Active Substance (Summary)
INN / Common Names
EMA Name
ImmunoGam
Medicine Name
ImmunoGam
Aliases
N/ANo risk management plan link.
