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Synagis(palivizumab)
Synagis (palivizumab) is an antibody pharmaceutical. Palivizumab was first approved as Synagis on 1998-06-19. It is used to treat respiratory syncytial virus infections in the USA. It has been approved in Europe to treat respiratory syncytial virus infections.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
Trade Name
FDA
EMA
Synagis
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Palivizumab
Tradename
Proper name
Company
Number
Date
Products
SynagispalivizumabSwedish Orphan Biovitrum AB (publ)N-103770 RX2004-07-23
2 products
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
synagis Biologic Licensing Application2020-12-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
respiratory syncytial virus infectionsEFO_1001413D018357—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
— J06: Immune sera and immunoglobulins
— J06B: Immunoglobulins
— J06BD: Antiviral monoclonal antibodies
— J06BD01: Palivizumab
HCPCS
Code
Description
S9562
Home injectable therapy, palivizumab, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem
Clinical
Clinical Trials
16 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory syncytial virus infectionsD018357EFO_1001413—34—16
Congenital heart defectsD006330HP_0001627Q24.9—21——2
Respiratory syncytial virusesD012136——1——1
Premature birthD047928EFO_0003917O60—11——1
Bronchopulmonary dysplasiaD001997P27.8—11——1
NeoplasmsD009369C80——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2————2
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePALIVIZUMAB
INNpalivizumab
Description
Immunoglobulin G 1 (human-mouse monoclonal MEDI-493y1-chain anti­respiratory syncytial virus protein F), disulfide with human-mouse monocional MEDI-493 x-chain, dimer
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)PALIVIZUMAB
Structure (InChI/SMILES or Protein Sequence)
>2HWZ:H|Immunoglobulin Fab heavy chain QVTLRESGPALVKPTQTLTLTCTFSGFSLSTSGMSVGWIRQPPGKALEWLADIWWDDKKDYNPSLKSRLTISKDTSANQV VLKVTNMDPADTATYYCARSMITNWYFDVWGAGTTVTVSSASTKGPSVFPLAPSSAAAAGGTAALGCLVKDYFPEPVTVS WNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTH >2HWZ:L|Immunoglobulin Fab light chain DIQMTQSPSTLSASVGDRVTITCKCQLSVGYMHWYQQKPGKAPKLLIYDTSKLASGVPSRFSGSGSGTAFTLTISSLQPD DFATYYCFQGSGYPFTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQE SVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Identifiers
PDB2HWZ
CAS-ID188039-54-5
RxCUI194279
ChEMBL IDCHEMBL1201586
ChEBI ID—
PubChem CID—
DrugBankDB00110
UNII IDDQ448MW7KS (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Synagis - AbbVie
$
€
£
₣
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Synagis - AstraZeneca
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,797 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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41,583 adverse events reported
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