This brand name is authorized in Austria, Brazil, Spain, Finland, Ireland, Israel, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom
The drug HEPATECT contains one active pharmaceutical ingredient (API):
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1
Human hepatitis B immunoglobulin
UNII 6D53G0FD0Z - PLASMA PROTEIN FRACTION (HUMAN)
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| HEPATECT CP Solution for infusion | Medicines & Healthcare Products Regulatory Agency (GB) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system 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 |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 524617030002507, 524617070002607, 524617070002707 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 70955 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 067940, 083525, 377957, 456667 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 179591, 179595, 179599, 199419 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 6892 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 103381, 197033, 85928 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100215795 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W54188001, W54188002, W54188003, W54188004 |
| Country: SG | Health Sciences Authority | Identifier(s): 14652P |
| Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8699535980516, 8699535980547 |
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