Overview
Intravenous immunoglobulin (IVIg) is a mixture of IgG1 and other antibodies derived from healthy human plasma via Cohn fractionation. The purification process includes cold alcohol fractionation, polyethylene glycol precipitation, and ion exchange chromatography. IVIg contains the same distribution of IgG antibody subclasses as is found in the general human population. IgG subclasses are fully represented in the following proportions: 70.3% IgG1, 24.7% IgG2, 3.1% IgG3, and 1.9% IgG4. IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders.
Indication
Human immunoglobulin G is indicated for the following conditions:
Associated Conditions
- Acute Idiopathic Thrombocytopenic Purpura
- Bacterial Infections
- Chronic Idiopathic Thrombocytopenic Purpura
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Coronary Artery Aneurysm
- Dermatomyositis (DM)
- Hepatitis A
- Measles
- Multifocal Motor Neuropathy (MMN)
- Primary humoral immunodeficiency
- Rubella
- Secondary humoral immunodeficiency
- Varicella
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/17 | Phase 1 | Active, not recruiting | |||
2025/05/16 | Phase 2 | Recruiting | |||
2025/05/01 | Phase 3 | Recruiting | On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA. | ||
2025/03/26 | Phase 1 | Completed | |||
2025/02/19 | Phase 1 | Recruiting | M. Peter Marinkovich | ||
2024/12/31 | Phase 1 | Active, not recruiting | Arialys Therapeutics | ||
2024/12/24 | Phase 3 | Recruiting | |||
2024/07/29 | Phase 3 | Terminated | |||
2023/04/27 | Phase 2 | Recruiting | |||
2023/03/06 | Phase 2 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc | 0069-1011 | Intravenous | 100 mg in 1 mL | 4/4/2025 | |
| ADMA Biologics, Inc. | 69800-6502 | INTRAVENOUS | 5 g in 50 mL | 3/15/2024 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-1415 | INTRAVENOUS | 100 mg in 1 mL | 4/4/2025 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-1109 | INTRAVENOUS | 100 mg in 1 mL | 4/4/2025 | |
| CSL Behring AG | 44206-439 | INTRAVENOUS | 40 g in 400 mL | 5/22/2025 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-1224 | INTRAVENOUS | 100 mg in 1 mL | 4/4/2025 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-1558 | INTRAVENOUS | 100 mg in 1 mL | 4/4/2025 | |
| ADMA Biologics, Inc. | 69800-6503 | INTRAVENOUS | 10 g in 100 mL | 3/15/2024 | |
| CSL Behring AG | 44206-438 | INTRAVENOUS | 20 g in 200 mL | 5/22/2025 | |
| CSL Behring AG | 44206-437 | INTRAVENOUS | 10 g in 100 mL | 5/22/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/23/2007 | ||
Authorised | 5/16/2013 | ||
Authorised | 5/16/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| IMMUNOGLOBULINS SG INJECTION 50mg/ml | SIN16766P | INJECTION | 50mg/ml | 4/20/2023 | |
| Kiovig Solution for Infusion 100mg/ml | SIN13809P | INFUSION, SOLUTION | 100mg/ml | 5/21/2010 | |
| GAMUNEX®-C SOLUTION FOR INFUSION 10% | SIN14928P | INJECTION, SOLUTION | 0.1g /mL | 1/26/2016 | |
| Igantibe 200 IU/ml | SIN11003P | INJECTION | 200 iu/ml | 6/30/1999 | |
| GAMMAGARD S/D FOR INJECTION | SIN08493P | INJECTION, POWDER, FOR SOLUTION | 48-56 mg/ml | 12/13/1995 | |
| FLEBOGAMMA DIF SOLUTION FOR INFUSION 5% | SIN13960P | INFUSION, SOLUTION | 50 mg/ml | 5/20/2011 | |
| Intratect solution for infusion 50g/l | SIN14178P | INFUSION, SOLUTION | 50 mg/ml | 6/26/2012 | |
| PRIVIGEN SOLUTION FOR INFUSION 100g/L | SIN15574P | INFUSION, SOLUTION | 100g/L | 11/7/2018 | |
| FLEBOGAMMA DIF SOLUTION FOR INFUSION 10% | SIN14158P | INFUSION, SOLUTION | 100mg/ml | 6/14/2012 | |
| Ig VENA Solution for Infusion 50g/l | SIN14050P | INFUSION, SOLUTION | 50mg/ml | 11/11/2011 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| IG VENA SOLUTION FOR INFUSION 10G/200ML | N/A | N/A | N/A | 1/5/2012 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OCTAGAM 5% | octapharma pharmazeutika produktionsges m b h | 02267713 | Solution - Intravenous | 50 MG / ML | N/A |
| IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% | 02230920 | Solution - Intravenous | 10 G / 100 ML | 7/31/2000 | |
| HYQVIA | takeda canada inc | 02524406 | Solution - Subcutaneous | 30 G / 300 ML | 11/7/2023 |
| GAMIMUNE N 10% (IV) | 02229695 | Solution - Intravenous | 100 MG / ML | 5/16/2000 | |
| CUTAQUIG | octapharma pharmazeutika produktionsges m b h | 02473003 | Solution - Subcutaneous | 1.65 G / 10 ML | N/A |
| VIVAGLOBIN | csl behring canada inc | 02282518 | Solution - Subcutaneous | 160 MG / ML | 3/1/2007 |
| SANDOGLOBULIN NF LIQUID | csl behring canada inc | 02287994 | Solution - Intravenous | 120 G / L | 6/28/2007 |
| FLEBOGAMMA 10% | 02467526 | Solution - Intravenous | 100 MG / ML | N/A | |
| GAMIMUNE N 5% (IV) | 02178842 | Solution - Intravenous | 50 MG / ML | 1/17/1997 | |
| OCTAGAM | octapharma pharmazeutika produktionsges m b h | 02380145 | Solution - Intravenous | 100 MG / ML | 4/4/2013 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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