Overview
Humanized monoclonal antibody (IgG1k) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Synagis is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor (1) and Cess (2). The human lightchain sequence was derived from the constant domain of Ck and the variable framework regions of the VL gene K104 withJk-4. Palivizumab is expressed from a stable murine (mouse) myeloma cell line (NS0). Palivizumab is composed of to heavy chains (50.6 kDa each) and two light chains (27.6 kDa each), contains 1-2% carbohydrate by weight and has a molecular weight of 147.7 kDa +/- 1 kDa (MALDI-TOF)
Indication
For prophylaxis of respiratory diseases casued by respiratory syncytial virus.
Associated Conditions
- Severe Respiratory Syncytial Virus Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/06/24 | Phase 3 | Completed | |||
2020/09/07 | Phase 1 | Completed | mAbxience Research S.L. | ||
2019/05/22 | Phase 2 | Completed | |||
2016/11/18 | Phase 3 | Completed | |||
2015/05/13 | Phase 3 | Completed | |||
2011/11/06 | Phase 3 | Completed | |||
2005/10/18 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Swedish Orphan Biovitrum AB (publ) | 66658-230 | INTRAMUSCULAR | 50 mg in 0.5 mL | 11/17/2020 | |
| Swedish Orphan Biovitrum AB (publ) | 66658-231 | INTRAMUSCULAR | 100 mg in 1 mL | 11/17/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/13/1999 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SYNAGIS SOLUTION FOR INJECTION 100MG/ML | SIN15112P | INJECTION, SOLUTION | 100mg/ml | 11/7/2016 |
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 |
|---|---|---|---|---|---|
| SYNAGIS palivizumab (rmc) 50 mg / 0.5 mL solution for injection vial | 231133 | Medicine | A | 9/24/2015 | |
| SYNAGIS palivizumab (rmc) 100 mg / 1 mL solution for injection vial | 231139 | Medicine | A | 9/24/2015 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SYNAGIS | astrazeneca canada inc | 02438372 | Solution - Intramuscular | 50 MG / 0.5 ML | 11/3/2016 |
| SYNAGIS | astrazeneca canada inc | 02438364 | Solution - Intramuscular | 100 MG / ML | 11/3/2016 |
| SYNAGIS | 02245890 | Powder For Solution - Intramuscular | 100 MG / VIAL | 9/26/2002 | |
| SYNAGIS | 02245889 | Powder For Solution - Intramuscular | 50 MG / VIAL | 9/26/2002 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| SYNAGIS 50 mg/0,5 ml SOLUCION INYECTABLE | 199117003 | SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
| SYNAGIS 100 mg/1 ml SOLUCION INYECTABLE | 199117004 | SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
| SYNAGIS 50 mg POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 99117001 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
| SYNAGIS 100 mg POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 99117002 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized |
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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