ImmunoGam
Withdrawn
This medicine's authorisation has been withdrawn
human hepatitis B immunoglobulin
Medicine
Human
Withdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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.
Product information
06/09/2010
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
- ImmunoGam
- Active substance
- human hepatitis B immunoglobulin
- International non-proprietary name (INN) or common name
- human hepatitis B immunoglobulin
- Therapeutic area (MeSH)
- Immunization, Passive
- Hepatitis B
- Anatomical therapeutic chemical (ATC) code
- J06BB04
Pharmacotherapeutic group
Specific immunoglobulinsTherapeutic 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.
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