Palivizumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
1998
- First approval year
- 1998
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Palivizumab
- synagis
- Synagis
- synagis abbosynagis
- Synagis abbosynagis
- immunoglobulin g1 anti respiratory syncytial virus protein f human mouse monoclonal medi 493 gamma 1 chain disulfide with human mouse monoclonal medi 493 kappa chain dimer
- immunoglobulin g1 anti respiratory syncytial virus protein f human mouse monoclonal medi 493 gamma 1 chain disulphide with human mouse monoclonal medi 493 kappa chain dimer
- IMMUNOGLOBULIN G1, ANTI-(RESPIRATORY SYNCYTIAL VIRUS PROTEIN F)(HUMAN-MOUSE MONOCLONAL MEDI-493 .GAMMA.1-CHAIN), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL MEDI-493 .KAPPA.-CHAIN, DIMER
- IMMUNOGLOBULIN G1, ANTI-(RESPIRATORY SYNCYTIAL VIRUS PROTEIN F)(HUMAN-MOUSE MONOCLONAL MEDI-493 .GAMMA.1-CHAIN), DISULPHIDE WITH HUMAN-MOUSE MONOCLONAL MEDI-493 .KAPPA.-CHAIN, DIMER
- medi 493
- MEDI-493
- palivizumab
- Palivizumab
- PALIVIZUMAB [EMA EPAR]
- palivizumab [INN]
- PALIVIZUMAB [JAN]
- PALIVIZUMAB [MART.]
- PALIVIZUMAB [MI]
- PALIVIZUMAB [PURPLE BOOK CDER]
- PALIVIZUMAB [USAN]
- PALIVIZUMAB [VANDF]
- Palivizumab [WHO-DD]
- palivizumab ema epar
- palivizumab inn
- palivizumab jan
- palivizumab mart
- palivizumab mi
- palivizumab purple book cder
- palivizumab usan
- palivizumab vandf
And 1 more, listed on the interactive page.
- ATC classification codes
- J06BD01
Sources for recorded values
- CAS registry numbers
- 188039-54-5
- ChEMBL ID
- CHEMBL1201586
- RxNorm IDs (RxCUI)
- 194279
- FDA ingredient codes (UNII)
- DQ448MW7KS
- Applicant
- SWEDISH ORPHAN
- Approval date
- 19 Jun 1998
- Application number
- BLA103770
- Status
- Authorised
- Status date
- 13 Aug 1999
- Authorisation date
- 13 Aug 1999
- Approved indications
- Synagis is indicated for the prevention of serious lower-respiratory-tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease: children born at 35 weeks of gestation or less and less than six months of age at the onset of the RSV season; children less than two years of age and requiring treatment for bronchopulmonary dysplasia within the last six months; children less than two years of age and with haemodynamically significant congenital heart disease.
- Product number
- EMEA/H/C/000257
- Authorisation holder
- AstraZeneca AB
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Respiratory Syncytial Virus Infections
European medicines record
- Patents
- 0
- Designations
- 1
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Drug name stem
- -mab; -mab
Administration routes
- Parenteral
Mechanisms of action
- Mechanism
- Fusion glycoprotein F0 inhibitor
- Action type
- Inhibitor
- Target
- Fusion glycoprotein F0
- Protein identifier
- Q89535
Open Targets mechanisms
- Mechanism
- Fusion glycoprotein F0 inhibitor
- Action type
- Inhibitor
- Target
- Fusion glycoprotein F0
- Condition
- Respiratory Tract Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000684
- Subject identifier
- D012140
- Condition
- Hernias, Diaphragmatic, Congenital
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005207
- Subject identifier
- D065630
- Condition
- Respiratory Syncytial Virus Infections
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001413
- Subject identifier
- D018357
- Condition
- Bronchopulmonary Dysplasia
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0019091
- Subject identifier
- D001997
- Condition identifier
- EFO_0000684
- Condition identifier
- EFO_0005207
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001413
- Condition identifier
- MONDO_0001577
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0002465
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005087
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0019091
- Condition identifier
- MONDO_0019091
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0100286
- Highest recorded phase
- 3
- Event
- abdominal pain
- Reports
- 11
- Reporting signal score
- 59.5805
- Event
- abdominal pain upper
- Reports
- 2
- Reporting signal score
- 48.5667
- Event
- acute kidney injury
- Reports
- 1
- Reporting signal score
- 61.9178
- Event
- adenovirus infection
- Reports
- 27
- Reporting signal score
- 60.6938
- Event
- anxiety
- Reports
- 2
- Reporting signal score
- 62.0407
- Event
- apnoea
- Reports
- 182
- Reporting signal score
- 523.075
- Event
- arthralgia
- Reports
- 2
- Reporting signal score
- 119.316
- Event
- asthenia
- Reports
- 20
- Reporting signal score
- 69.1595
- Event
- bronchiolitis
- Reports
- 629
- Reporting signal score
- 3,087.98
- Event
- bronchitis
- Reports
- 275
- Reporting signal score
- 390.06
- Event
- bronchopneumonia
- Reports
- 29
- Reporting signal score
- 65.6045
- Event
- bronchopulmonary dysplasia
- Reports
- 37
- Reporting signal score
- 125.41
- Event
- cardiac operation
- Reports
- 56
- Reporting signal score
- 134.758
- Event
- cough
- Reports
- 410
- Reporting signal score
- 312.667
- Event
- covid-19
- Reports
- 149
- Reporting signal score
- 165.904
- Event
- croup infectious
- Reports
- 19
- Reporting signal score
- 62.422
- Event
- crying
- Reports
- 91
- Reporting signal score
- 126.819
- Event
- cyanosis
- Reports
- 129
- Reporting signal score
- 250.498
- Event
- drug hypersensitivity
- Reports
- 10
- Reporting signal score
- 75.1143
- Event
- drug interaction
- Reports
- 1
- Reporting signal score
- 81.9198
- Event
- dyspnoea
- Reports
- 359
- Reporting signal score
- 54.803
- Event
- ear infection
- Reports
- 57
- Reporting signal score
- 61.1794
- Event
- enterovirus infection
- Reports
- 19
- Reporting signal score
- 56.1478
- Event
- fall
- Reports
- 10
- Reporting signal score
- 86.6045
- Event
- fatigue
- Reports
- 66
- Reporting signal score
- 91.874
And 52 more, listed on the interactive page.
- NCT00014391
- NCT00129766
- NCT01466062
- NCT02968173
- NCT03959488
- NCT04938830
- NCT00538785
- Dose
- 15 mg per kg
- Route
- Intramuscular
- How often
- Monthly during RSV season
- Do not dilute
- Do not shake or vigorously agitate the vial
- Do not use gluteal muscle routinely
- Inject in anterolateral thigh
- Inject over 1 mL as divided doses if over 1 mL
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 66658-230
Related records
Trials (16)
- "Palivizumab Therapy for RSV-bronchiolitis"
- A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493, Synagis)
- A PK Study Comparing MB05, EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers.
- A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus
- A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease
- A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
- A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children
- Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
- Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions
- Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection
- Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With RSV
- Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
- Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation
- Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
- Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season
- Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease
Approved for (3)
- Bronchopulmonary dysplasia
- Respiratory syncytial virus infectious disease
- Respiratory system disorder
In development for (1)
- Congenital heart disease Phase 2