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Pharmaceuticals - Community Register
Community list of not active medicinal products for human use
|Auth. number :||EU/1/10/613|
|INN :||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
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register.
|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|