This brand name is authorized in Nigeria. It is also authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK, United States.
The drug HAVRIX contains one active pharmaceutical ingredient (API):
1
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UNII
5BFC8LZ6LQ - HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)
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Inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, highly purified, formalin inactivated, and then adsorbed onto amorphous aluminum hydroxyphosphate sulphate. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| A6-0444 | Suspension for injection | Havrix 1440 Vaccine INJ_SUSP 1 mL 1 ml | HEPATITIS A VIRUS (INACTIVATED) 1ml N/A Suspension for injection in 1 ml pre-filled syringe SUSPENSION GLAXOSMITHKLINE PHARMACEUTICAL NIGERIA LTD. GlaxoSmithKline Biologicals S.A., 89, Rue de l'Institut, 1330 Rixensart, Belgium 04/11/2023 30/10/2028 | 04/11/2023 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| J07BC02 | Hepatitis A, inactivated, whole virus | J Antiinfectives for systemic use → J07 Vaccines → J07B Viral vaccines → J07BC Hepatitis vaccines |
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 | 510603501159318, 510603502155316 |
| CA | Health Products and Food Branch | 02187078, 02231056 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 29615-1-02-11 |
| EE | Ravimiamet | 1020991, 1027000 |
| ES | Centro de información online de medicamentos de la AEMPS | 61250, 61396 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 472332, 498691, 585869 |
| FR | Base de données publique des médicaments | 60152436, 60386414 |
| GB | Medicines & Healthcare Products Regulatory Agency | 30037, 30039, 30064, 30065 |
| HK | Department of Health Drug Office | 40826, 42693 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 3217, 3572 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1008866, 1014296, 1066762 |
| MT | Medicines Authority | MA192/02201, MA192/02202, PI1438/02801A |
| NG | Registered Drug Product Database | A6-0444 |
| NL | Z-Index G-Standaard | 14076594, 14138476 |
| NL | Z-Index G-Standaard, PRK | 47961, 62022 |
| NZ | Medicines and Medical Devices Safety Authority | 6720, 6721 |
| PL | Rejestru Produktów Leczniczych | 100224297, 100224305 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W13311001, W13311002, W13311003, W57776001, W57776002, W57776003, W57776004, W57776005 |
| SG | Health Sciences Authority | 08683P, 09728P |
| TN | Direction de la Pharmacie et du Médicament | 2363031, 7063071 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699522967322, 8699522967346 |
| US | FDA, National Drug Code | 50090-1502, 58160-825, 58160-826 |
| ZA | Health Products Regulatory Authority | 29/30.1/0310, 31/30.1/0294 |
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