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01 2GUERBET

02 16Mallinckrodt Pharmaceuticals

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PharmaCompass

01

IPPE
Not Confirmed
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IPPE
Not Confirmed

Gadoversetamide

Brand Name : Optimark

Dosage Form : Injectable Solution

Dosage Strength : 500micromoles/ml

Packaging :

Approval Date : 23/07/2007

Application Number : 20060706000029

Regulatory Info : Deregistered

Registration Country : Sweden

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02

IPPE
Not Confirmed
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IPPE
Not Confirmed

Gadoversetamide

Brand Name : Optimark

Dosage Form : Solution For Injection

Dosage Strength : 500micromoles/ml

Packaging :

Approval Date : 23/07/2007

Application Number : 20060706000036

Regulatory Info : Deregistered

Registration Country : Sweden

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03

IPPE
Not Confirmed
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IPPE
Not Confirmed

GADOVERSETAMIDE

Brand Name : OPTIMARK

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1654.5MG/5ML (330.9MG/ML)

Packaging :

Approval Date : 1999-12-08

Application Number : 20937

Regulatory Info : DISCN

Registration Country : USA

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04

IPPE
Not Confirmed
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IPPE
Not Confirmed

GADOVERSETAMIDE

Brand Name : OPTIMARK

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 3309MG/10ML (330.9MG/ML)

Packaging :

Approval Date : 1999-12-08

Application Number : 20937

Regulatory Info : DISCN

Registration Country : USA

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05

IPPE
Not Confirmed
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IPPE
Not Confirmed

GADOVERSETAMIDE

Brand Name : OPTIMARK

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4963.5MG/15ML (330.9MG/ML)

Packaging :

Approval Date : 1999-12-08

Application Number : 20937

Regulatory Info : DISCN

Registration Country : USA

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06

IPPE
Not Confirmed
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IPPE
Not Confirmed

GADOVERSETAMIDE

Brand Name : OPTIMARK

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6618MG/20ML (330.9MG/ML)

Packaging :

Approval Date : 1999-12-08

Application Number : 20937

Regulatory Info : DISCN

Registration Country : USA

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07

IPPE
Not Confirmed
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IPPE
Not Confirmed

GADOVERSETAMIDE

Brand Name : OPTIMARK

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 16.545GM/50ML (330.9MG/ML)

Packaging :

Approval Date : 1999-12-08

Application Number : 20975

Regulatory Info : DISCN

Registration Country : USA

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08

IPPE
Not Confirmed
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IPPE
Not Confirmed

GADOVERSETAMIDE

Brand Name : OPTIMARK IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 9927MG/30ML (330.9MG/ML)

Packaging :

Approval Date : 1999-12-08

Application Number : 20976

Regulatory Info : DISCN

Registration Country : USA

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09

IPPE
Not Confirmed
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IPPE
Not Confirmed

GADOVERSETAMIDE

Brand Name : OPTIMARK IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 3309MG/10ML (330.9MG/ML)

Packaging :

Approval Date : 1999-12-08

Application Number : 20976

Regulatory Info : DISCN

Registration Country : USA

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10

IPPE
Not Confirmed
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IPPE
Not Confirmed

GADOVERSETAMIDE

Brand Name : OPTIMARK IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4963.5MG/15ML (330.9MG/ML)

Packaging :

Approval Date : 1999-12-08

Application Number : 20976

Regulatory Info : DISCN

Registration Country : USA

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11

IPPE
Not Confirmed
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IPPE
Not Confirmed

GADOVERSETAMIDE

Brand Name : OPTIMARK IN PLASTIC CONTAINER

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6618MG/20ML (330.9MG/ML)

Packaging :

Approval Date : 1999-12-08

Application Number : 20976

Regulatory Info : DISCN

Registration Country : USA

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12

IPPE
Not Confirmed
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IPPE
Not Confirmed

Gadoversetamide

Brand Name : Optimark

Dosage Form : Injectable Solution In A Vial

Dosage Strength : 500MMOL

Packaging :

Approval Date : 2007-12-11

Application Number : 07398002

Regulatory Info : Cancelled

Registration Country : Spain

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13

IPPE
Not Confirmed
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IPPE
Not Confirmed

Gadoversetamide

Brand Name : Optimark

Dosage Form : Injectable Solution In A Vial

Dosage Strength : 500MMOL

Packaging :

Approval Date : 2007-12-11

Application Number : 07398004

Regulatory Info : Cancelled

Registration Country : Spain

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14

IPPE
Not Confirmed
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IPPE
Not Confirmed

Gadoversetamide

Brand Name : Optimark

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 500MMOL

Packaging :

Approval Date : 2007-12-11

Application Number : 07398009

Regulatory Info : Cancelled

Registration Country : Spain

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15

IPPE
Not Confirmed
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IPPE
Not Confirmed

Gadoversetamide

Brand Name : Optimark

Dosage Form : Injectable Solution In A Vial

Dosage Strength : 500MMOL

Packaging :

Approval Date : 2007-12-11

Application Number : 07398006

Regulatory Info : Cancelled

Registration Country : Spain

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16

IPPE
Not Confirmed
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IPPE
Not Confirmed

Gadoversetamide

Brand Name : Optimark

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 500MMOL

Packaging :

Approval Date : 2007-12-11

Application Number : 07398011

Regulatory Info : Cancelled

Registration Country : Spain

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17

IPPE
Not Confirmed
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IPPE
Not Confirmed

Gadoversetamide

Brand Name : Optimark

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 500MMOL

Packaging :

Approval Date : 2007-12-11

Application Number : 07398013

Regulatory Info : Cancelled

Registration Country : Spain

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18

IPPE
Not Confirmed
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IPPE
Not Confirmed

Gadoversetamide

Brand Name : Optimark

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 500MMOL

Packaging :

Approval Date : 2007-12-11

Application Number : 07398007

Regulatory Info : Cancelled

Registration Country : Spain

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