Human hepatitis B immunoglobulin solution for infusion contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBs). It is used for the immunoprophylaxis of hepatitis B and the prevention of hepatitis B virus re-infection after liver transplantation for hepatitis B induced liver failure.
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| J06BB04 | Hepatitis B immunoglobulin | J Antiinfectives for systemic use → J06 Immune sera and immunoglobulins → J06B Immunoglobulins → J06BB Specific immunoglobulins |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| HEPATECT CP Solution for infusion | Medicines & Healthcare Products Regulatory Agency (GB) | MPI, EU: SmPC | |
| HEPAGAM B Solution for infusion | FDA, National Drug Code (US) | MPI, US: SPL/PLR | |
| HYPERHEP B Solution for injection | FDA, National Drug Code (US) | MPI, US: SPL/Old |
Human hepatitis B immunoglobulin is an active ingredient of these brands:
United States (US)Canada (CA)Estonia (EE)Finland (FI)
France (FR)Hong Kong (HK)Ireland (IE)
Israel (IL)
Japan (JP)New Zealand (NZ)Poland (PL)
Romania (RO)
Singapore (SG)
South Africa (ZA)Spain (ES)Turkey (TR)United Kingdom (UK)
Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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