This brand name is authorized in Austria, Brazil, Canada, Cyprus, Finland, France, Ireland, Israel, Netherlands, New Zealand, Poland, Spain, UK.
The drug GAMUNEX contains one active pharmaceutical ingredient (API):
1
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UNII
66Y330CJHS - HUMAN IMMUNOGLOBULIN G
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Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. Human normal immunoglobulin contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1000 donors. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| GAMUNEX 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 | |
|---|---|---|
| J06BA02 | Immunoglobulins, normal human, for intravascular adm. | J Antiinfectives for systemic use → J06 Immune sera and immunoglobulins → J06B Immunoglobulins → J06BA Immunoglobulins, normal human |
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 | 510918060004807, 510918060004907, 510918060005007, 510918060005107, 510918060005207 |
| CA | Health Products and Food Branch | 02247724 |
| ES | Centro de información online de medicamentos de la AEMPS | 82255 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 176559, 392185, 396162, 452480, 577162 |
| FR | Base de données publique des médicaments | 65006702 |
| GB | Medicines & Healthcare Products Regulatory Agency | 198048, 198050, 198052, 198391 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 6420 |
| NL | Z-Index G-Standaard | 15917460, 15917479 |
| NL | Z-Index G-Standaard, PRK | 80055, 80063, 80071 |
| NZ | Medicines and Medical Devices Safety Authority | 17968 |
| PL | Rejestru Produktów Leczniczych | 100175104 |
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