Synopsis
Synopsis
0
USDMF
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CEP/COS
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
Regulatory FDF Prices
NA
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API
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FDF
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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Regulatory Info :
Registration Country : USA
Brand Name : SOLIRIS
Dosage Form : INJECTABLE; IV (INFUSION)
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number : 125166
Regulatory Info :
Registration Country : USA

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Soliris
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 10mg/ml
Packaging :
Approval Date : 20/06/2007
Application Number : 20061202000018
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Soliris
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 300mg/30ml
Packaging :
Approval Date : 04/01/2010
Application Number : 59282
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Soliris
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 300MG
Packaging :
Approval Date : 2007-08-07
Application Number : 07393001
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : SOLIRIS
Dosage Form : SOLUTION
Dosage Strength : 10MG/ML
Packaging : 30ML
Approval Date :
Application Number : 2322285
Regulatory Info : Schedule D
Registration Country : Canada

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Regulatory Info :
Registration Country : USA
Brand Name : BKEMV
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 300MG/30ML(10MG/ML)
Packaging :
Approval Date :
Application Number : 761333
Regulatory Info :
Registration Country : USA

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Bekemv
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 300mg
Packaging :
Approval Date : 19/04/2023
Application Number : 20220304000061
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Bekemv
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 300MG
Packaging :
Approval Date : 2023-04-27
Application Number : 1231727001
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info :
Registration Country : USA
Brand Name : EPYSQLI
Dosage Form : INJECTION;SOLUTION
Dosage Strength : 300 mg/30 mL (10 mg/mL)
Packaging :
Approval Date :
Application Number : 761340
Regulatory Info :
Registration Country : USA

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Epysqli
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 300mg
Packaging :
Approval Date : 26/05/2023
Application Number : 20220623000025
Regulatory Info : Approved
Registration Country : Sweden

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