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Community list of not active medicinal products for human use


Product information

Invented name: ImmunoGam
Auth. number : EU/1/10/613
Active substance : Human Hepatitis B Immunoglobulin
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J06 - Immune sera and immunoglobulins
Pharmacological subgroup: J06B - Immunoglobulins
Chemical subgroup: J06BB - Specific immunoglobulins
Chemical substance: J06BB04 - hepatitis B immunoglobulin
(See WHO ATC Index)
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 imtramuscular use.
Marketing Authorisation Holder: Cangene Europe Limited
Parkshot House, 5 Kew Road, Richmond, Surrey TW9 2PR, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
17/03/2010 Centralised - Authorisation EMEA/H/C/1055 (2010)1810 of 15/03/2010
09/09/2010 Centralised - Withdrawal (2010)6238 of 06/09/2010