ImmunoGam (human hepatitis B immunoglobulin)
- Region
- 🇪🇺 EU
- Active substance
- human hepatitis B immunoglobulin
- Company
- Cangene Europe Limited
- Status
- Withdrawn
- Therapeutic area
- Immunization, Passive; Hepatitis B
- EU approval
- Tue 16 Mar 2010
- Application
- EMEA/H/C/001055
- ATC
- J06BB04
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Zutectra Authorised · Biotest Pharma GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.