This brand name is authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug INFANRIX HEXA contains a combination of these active pharmaceutical ingredients (APIs):
1
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3U7E3O07S8 - CORYNEBACTERIUM DIPHTHERIAE
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2
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K3W1N8YP13 - CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
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3
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4
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8C367IY4EY - BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)
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5
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2QNL82089R - BORDETELLA PERTUSSIS
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6
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IFJ010MNE4 - HEPATITIS B VIRUS HBSAG SURFACE PROTEIN ANTIGEN
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Hepatitis B vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg). Hepatitis B vaccine has been recognized as the first anti-cancer vaccine because it can prevent primary liver cancer. |
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7
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0LVY784C09 - POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)
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8
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23JE9KDF4R - POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)
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9
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459ROM8M9M - POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)
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10
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FLV5I5W26R - HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN
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Haemophilus influenza type B (Hib) is a bacteria responsible for severe pneumonia, meningitis and other invasive diseases almost exclusively in young children. Vaccines are the only public health tool capable of preventing the majority of serious Hib disease. |
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This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| J07CA09 | Diphtheria-Haemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B | J Antiinfectives for systemic use → J07 Vaccines → J07C Bacterial and viral vaccines, combined → J07CA Bacterial and viral vaccines, combined |
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 | 510604101154317 |
| CA | Health Products and Food Branch | 02253852 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 61-MBE-0716 |
| EE | Ravimiamet | 1103375, 1103386, 1103397, 1103409, 1478910, 1478921 |
| ES | Centro de información online de medicamentos de la AEMPS | 00152005, 00152006 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 005870 |
| FR | Base de données publique des médicaments | 62966063 |
| GB | Medicines & Healthcare Products Regulatory Agency | 347659 |
| HK | Department of Health Drug Office | 48745 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1014070, 1028514, 1028517, 1028518, 1075259 |
| NL | Z-Index G-Standaard | 14952149 |
| NL | Z-Index G-Standaard, PRK | 121509 |
| NZ | Medicines and Medical Devices Safety Authority | 9054 |
| PL | Rejestru Produktów Leczniczych | 100108007 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W13411001, W13411002, W13411003, W13411004, W13411005, W13411006, W13411007, W13411008, W13411009, W13411010, W52744001, W52744002, W52744003, W52744004, W52744005, W52744006, W52744007, W52744008 |
| SG | Health Sciences Authority | 12288P |
| TN | Direction de la Pharmacie et du Médicament | 2363051 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699522967537 |
| ZA | Health Products Regulatory Authority | 36/30.1/0347 |
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