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Approved Marketing Authorisations (MA) containing Tedelparin in Europe. Original Data : EMA Website

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01 1PFIZER ITALIA Srl

02 6PFIZER LTD (SANDWICH UK)

03 13Pfizer AS

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PharmaCompass

01

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Tedelparin

Brand Name : Fragmin

Dosage Form : Dalteparin 10.000Iu 4 Units Parenteral Use

Dosage Strength : 4 Syringes SC 10,000 IU 0.4 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Tedelparin

Brand Name : Fragmin

Dosage Form : Dalteparin 12.500Iu 4 Units Parenteral Use

Dosage Strength : 4 Syringes SC 12,500 IU 0.5 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Tedelparin

Brand Name : Fragmin

Dosage Form : Dalteparin 15.000Iu 4 Units Parenteral Use

Dosage Strength : 4 Syringes SC 15,000 IU 0.6 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Tedelparin

Brand Name : Fragmin

Dosage Form : Dalteparin 2.500Iu 6 Units Parenteral Use

Dosage Strength : 6 Syringes SC 2,500 IU 0.2 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Tedelparin

Brand Name : Fragmin

Dosage Form : Dalteparin 5.000Iu 6 Units Parenteral Use

Dosage Strength : 6 Syringes SC 5,000 IU 0.2 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Tedelparin

Brand Name : Fragmin

Dosage Form : Dalteparin 7.500Iu 4 Units Parenteral Use

Dosage Strength : 4 Syringes SC 7,500 IU 0.3 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Tedelparin

Brand Name : Fragmin

Dosage Form :

Dosage Strength : 4 Syringes Sc 7,500 Iu 0.3 Ml  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Tedelparin

Brand Name : Fragmin

Dosage Form : Injection fluid, resolution with the conservation agent

Dosage Strength : 10000 IE anti-Xa/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Tedelparin

Brand Name : Fragmin

Dosage Form : Injection fluid, resolution

Dosage Strength : 12 500 IE anti-Xa/ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Tedelparin

Brand Name : Fragmin

Dosage Form : Injection fluid, resolution

Dosage Strength : 12 500 IE anti-Xa/ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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