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01 16Bracco

02 2Hainan Poly Pharm

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PharmaCompass

01

OPRD
Not Confirmed
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OPRD
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GADOTERIDOL

Brand Name : PROHANCE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 279.3MG/ML

Packaging :

Approval Date : 1992-11-16

Application Number : 20131

Regulatory Info : RX

Registration Country : USA

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02

OPRD
Not Confirmed
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OPRD
Not Confirmed

GADOTERIDOL

Brand Name : PROHANCE MULTIPACK

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 279.3MG/ML

Packaging :

Approval Date : 2003-10-09

Application Number : 21489

Regulatory Info : RX

Registration Country : USA

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03

OPRD
Not Confirmed
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OPRD
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Gadoteridol

Brand Name : Prohance

Dosage Form : Gadoteridol 1.396,5Mg 5Ml 1 Units Parenteral Use

Dosage Strength : 1 ampoule EV 5 ml 279,3 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

OPRD
Not Confirmed
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OPRD
Not Confirmed

Gadoteridol

Brand Name : Prohance

Dosage Form : Gadoteridol 13.965Mg 50Ml 1 Units Parenteral Use

Dosage Strength : 1 bottle EV 50 ml 279,3 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

OPRD
Not Confirmed
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OPRD
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Gadoteridol

Brand Name : Prohance

Dosage Form : Gadoteridol 2.793Mg 10Ml 1 Units Parenteral Use

Dosage Strength : 1 ampoule EV 10 ml 279,3 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

OPRD
Not Confirmed
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OPRD
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Gadoteridol

Brand Name : Prohance

Dosage Form : Gadoteridol 4.189,5Mg 15Ml 1 Units Parenteral Use

Dosage Strength : 1 ampoule EV 15 ml 279,3 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

OPRD
Not Confirmed
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OPRD
Not Confirmed

Gadoteridol

Brand Name : Prohance

Dosage Form : Gadoteridol 5.586Mg 20Ml 1 Units Parenteral Use

Dosage Strength : 1 ampoule EV 20 ml 279,3 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

OPRD
Not Confirmed
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OPRD
Not Confirmed

Gadoteridol

Brand Name : ProHance

Dosage Form : Injection fluid, resolution

Dosage Strength : 279,3 mg/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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09

OPRD
Not Confirmed
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OPRD
Not Confirmed

Gadoteridol

Brand Name : ProHance

Dosage Form : Injection fluid, resolution

Dosage Strength : 279,3 mg/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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10

OPRD
Not Confirmed
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OPRD
Not Confirmed

Gadoteridol

Brand Name : ProHance

Dosage Form : Injection fluid, resolution

Dosage Strength : 279,3 mg/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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11

OPRD
Not Confirmed
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OPRD
Not Confirmed

Gadoteridol

Brand Name : ProHance

Dosage Form : Injection fluid, resolution

Dosage Strength : 279,3 mg/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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12

OPRD
Not Confirmed
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OPRD
Not Confirmed

GADOTERIDOL

Brand Name : PROHANCE

Dosage Form : SOLUTION

Dosage Strength : 279.3MG/ML

Packaging : 10/15/17/20/50ML

Approval Date :

Application Number : 2229056

Regulatory Info :

Registration Country : Canada

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13

OPRD
Not Confirmed
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OPRD
Not Confirmed

Gadoteridol

Brand Name : Prohance

Dosage Form : Injectable Solution

Dosage Strength : 279.3mg/ml

Packaging :

Approval Date : 02/04/1993

Application Number : 19930402000026

Regulatory Info : Approved

Registration Country : Sweden

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14

OPRD
Not Confirmed
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OPRD
Not Confirmed

Gadoteridol

Brand Name : Prohance

Dosage Form : Solution For Injection

Dosage Strength : 279.3mg/ml

Packaging :

Approval Date : 09/08/2019

Application Number : 20180607000048

Regulatory Info : Approved

Registration Country : Sweden

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15

OPRD
Not Confirmed
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OPRD
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Gadoteridol

Brand Name : ProHance mmolml

Dosage Form : Solution For Injection

Dosage Strength : 279.3mg/ml

Packaging :

Approval Date : 29/08/1995

Application Number : 52273

Regulatory Info : Allowed

Registration Country : Switzerland

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16

OPRD
Not Confirmed
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OPRD
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Gadoteridol

Brand Name : ProHance mmolml

Dosage Form : Solution For Injection

Dosage Strength : 0.5mmol/ml

Packaging :

Approval Date : 15/12/2000

Application Number : 52599

Regulatory Info : Allowed

Registration Country : Switzerland

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17

OPRD
Not Confirmed
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OPRD
Not Confirmed

GADOTERIDOL

Brand Name : GADOTERIDOL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 279.3MG/ML

Packaging :

Approval Date : 2025-02-11

Application Number : 218749

Regulatory Info : RX

Registration Country : USA

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18

OPRD
Not Confirmed
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OPRD
Not Confirmed

Gadoteridol

Brand Name :

Dosage Form : Injection

Dosage Strength : 279.3MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : China

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