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