MedPath

Gadodiamide

Generic Name
Gadodiamide
Brand Names
Omniscan
Drug Type
Small Molecule
Chemical Formula
C16H26GdN5O8
CAS Number
131410-48-5
Unique Ingredient Identifier
84F6U3J2R6

Overview

Gadodiamide is a paramagnetic gadolinium-based contrast agent (GBCA) that is used in MR imaging procedures to assist in the visualization of blood vessels. It is intravenously injected and is commonly marketed under the trade name Omniscan.

Indication

For intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues.

Associated Conditions

  • Stenosis
  • Abnormal vascularity

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
GE Healthcare Inc.
0407-0690
INTRAVENOUS
287 mg in 1 mL
1/31/2024
GE Healthcare Inc.
0407-0690
INTRAVENOUS
287 mg in 1 mL
10/25/2018
GE Healthcare Inc.
0407-0691
INTRAVENOUS
287 mg in 1 mL
1/31/2024

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.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
OMNISCAN LIQ IV 287MG/ML
sanofi canada, inc.
02093197
Liquid - Intravenous
287 MG / ML
12/31/1994
OMNISCAN
ge healthcare canada inc
02172771
Solution - Intravenous
287 MG / ML
3/25/1997

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
OMNISCAN 0,5 mmol/ml SOLUCION INYECTABLE
Ge Healthcare Bio-Sciences, S.A.U.
62699
SOLUCIÓN INYECTABLE
Uso Hospitalario Y Centros De Diagnóstico Autorizados
Not Commercialized
OMNISCAN 0,5 mmol/ml SOLUCION INYECTABLE EN JERINGA PRECARGADA
Ge Healthcare Bio-Sciences, S.A.U.
60331
SOLUCIÓN INYECTABLE
Uso Hospitalario Y Centros De Diagnóstico Autorizados
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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