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ImmunoGam

Active Substance: human hepatitis B immunoglobulin
Common Name: human hepatitis B immunoglobulin
ATC Code: J06B B04
Marketing Authorisation Holder: Cangene Europe Limited
Active Substance: human hepatitis B immunoglobulin
Status: Withdrawn
Authorisation Date: 2010-03-16
Therapeutic Area: Immunization, Passive Hepatitis B
Pharmacotherapeutic Group: Specific immunoglobulins

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.

The marketing authorisation for ImmunoGam has been withdrawn at the request of the marketing authorisation holder.

Source: European Medicines Agency

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