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Drug ReportsGadobutrol
Gadobutrol
Gadavist, Gadobutrol (gadobutrol) is a small molecule pharmaceutical. Gadobutrol was first approved as Gadavist on 2011-03-14.
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Drug
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Variants
Financial
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Events Timeline
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YTD
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2Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Gadavist, Gadobutrol
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gadobutrol
Tradename
Company
Number
Date
Products
GADAVISTBayerN-201277 RX2011-03-14
6 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
gadavistNew Drug Application2024-07-23
gadobutrolANDA2024-10-24
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
GADOBUTROL, GADOBUTROL, HENGRUI PHARMA
2024-04-29CGT
Patent Expiration
No data
ATC Codes
V: Various drug classes in atc
V08: Contrast media
V08C: Magnetic resonance imaging contrast media
V08CA: Paramagnetic contrast media
V08CA09: Gadobutrol
HCPCS
Code
Description
A9585
Injection, gadobutrol, 0.1 ml
Clinical
No data
Drug
General
Drug common nameGadobutrol
INNgadobutrol
Description
Gadobutrol (INN) (Gd-DO3A-butrol) is a gadolinium-based MRI contrast agent (GBCA).
Classification
Small molecule
Drug classgadolinium derivatives (principally for diagnostic use)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID770691-21-9
RxCUI
ChEMBL IDCHEMBL2218860
ChEBI ID
PubChem CID72057
DrugBankDB06703
UNII ID1BJ477IO2L (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
Black-box warning for: Gadavist, Gadobutrol
Adverse Events
0 adverse events reported
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