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01 1F. Hoffmann-La Roche
02 11Roche Diagnostics GmbH
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01 11Injectable Solution In Pre-Filled Syringe
02 1SOLUTION; INJECTION
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01 11Authorized
02 1Blank
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01 1MIRCERA
02 11Mircera
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01 11Spain
02 1USA
Regulatory Info :
Registration Country : USA
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA
Brand Name : MIRCERA
Dosage Form : SOLUTION; INJECTION
Dosage Strength : 0.6MG/KG
Packaging :
Approval Date :
Application Number : 125164
Regulatory Info :
Registration Country : USA
Regulatory Info : Authorized
Registration Country : Spain
Methoxy-Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 250MCG
Packaging :
Approval Date : 2007-07-31
Application Number : 07400013
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Methoxy-Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 30MCG
Packaging :
Approval Date : 2008-09-24
Application Number : 07400017
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Methoxy-Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 75MCG
Packaging :
Approval Date : 2007-07-31
Application Number : 07400009
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Methoxy-Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 50MCG
Packaging :
Approval Date : 2007-07-31
Application Number : 07400008
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Methoxy-Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 75MCG
Packaging :
Approval Date : 2024-05-29
Application Number : 07400009IP
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Methoxy-Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 36MCG
Packaging :
Approval Date : 2008-09-24
Application Number : 07400021
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Methoxy-Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 200MCG
Packaging :
Approval Date : 2007-07-31
Application Number : 07400012
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Methoxy-Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 120MCG
Packaging :
Approval Date : 2008-09-24
Application Number : 07400020
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Methoxy-Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 100MCG
Packaging :
Approval Date : 2007-07-31
Application Number : 07400010
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Methoxy-Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 100MCG
Packaging :
Approval Date : 2024-05-27
Application Number : 07400010IP
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Methoxy-Polyethylene Glycol-Epoetin Beta
Brand Name : Mircera
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 150MCG
Packaging :
Approval Date : 2007-07-31
Application Number : 07400011
Regulatory Info : Authorized
Registration Country : Spain