Overview
Human varicella-zoster immune globulin is a solvent/detergent-treated sterile liquid preparation of purified human immune globulin G (IgG) containing antibodies to varicella zoster virus (anti-VZV). It is prepared from pools of healthy human donors' plasma via anion-exchange column chromatography and was approved in 2012 under the name VariZIG to reduce the disease severity in high-risk patients who lack evidence of immunity to varicella and for whom varicella vaccine is contraindicated. The therapeutic efficacy is proven if administered within 4 days of exposure to varicella zoster virus.
Indication
Indicated for preventing and reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals within 4 days of exposure to varicella zoster virus.
Associated Conditions
- Varicella Zoster Virus Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/10/05 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Saol Therapeutics | 70257-126 | INTRAMUSCULAR | 125 [iU] in 1.2 mL | 3/22/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| VARICELLA-ZOSTER IMMUNE GLOBULIN (HUMAN) | massachusetts public health biologic laboratories | 02231277 | Liquid - Intramuscular | 100 UNIT / ML | 7/24/2000 |
| VARIZIG | ki biopharma llc | 02442183 | Solution - Intravenous
,
Intramuscular | 125 UNIT / VIAL | 8/14/2015 |
| VARIZIG | cangene corporation a subsidiary of emergent biosolutions inc. | 02243342 | Kit - Intravenous
,
Intramuscular | 125 UNIT / VIAL | 2/13/2006 |
| VARICELLA ZOSTER IMMUNE GLOBULIN INJ | massachusetts public health biologic laboratories | 00554286 | Liquid - Intramuscular | 125 UNIT / 2.5 ML | 1/26/1982 |
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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