| EMA number | EMEA/H/C/001055 |
| ATC code | J06BB04 |
| Authorisation | 16 March 2010 |
| Withdrawn | 6 September 2010 |
| Revision | - |
Immunoprophylaxis of Hepatitis B - In case of accidental exposure in non-immunised subjects (including persons whose vaccination isincomplete 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.