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01 1Eugia Pharma (Malta) Limited
02 1Frostpharma Ab
03 3Orifarm Ab
04 2Pfizer AS
05 1Pfizer Ab
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01 1Fosphenytoin
02 4Fosphenytoin Sodium (Anhydrous)
03 2Fosphenytoin Sodium Heptahydrate
04 1Fosphenytoin disodium
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01 4Concentrate For Solution For Infusion Or Injection
02 1Concentrate for injection/infusion solution, solution
03 2Injectable Solution
04 1To concentrate the Injection/infusion fluid, resolution
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01 2Norway
02 6Sweden
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01 1Fosphenytoin Eugia
02 1Fosphenytoin Frost
03 6Pro-Epanutin
Regulatory Info : Approved
Registration Country : Sweden
Fosphenytoin Sodium Heptahydrate
Brand Name : Fosphenytoin Eugia
Dosage Form : Injectable Solution
Dosage Strength : 75mg/ml
Packaging :
Approval Date : 18/10/2022
Application Number : 20210723000049
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Fosphenytoin Sodium (Anhydrous)
Brand Name : Pro-Epanutin
Dosage Form : Concentrate For Solution For Infusion Or Injection
Dosage Strength : 75mg/ml
Packaging :
Approval Date : 20/03/2019
Application Number : 20181003000014
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Fosphenytoin Sodium (Anhydrous)
Brand Name : Pro-Epanutin
Dosage Form : Concentrate For Solution For Infusion Or Injection
Dosage Strength : 75mg/ml
Packaging :
Approval Date : 21/02/2023
Application Number : 20220818000014
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Fosphenytoin Sodium (Anhydrous)
Brand Name : Pro-Epanutin
Dosage Form : Concentrate For Solution For Infusion Or Injection
Dosage Strength : 75mg/ml
Packaging :
Approval Date : 08/12/2020
Application Number : 20200731000087
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Pro-Epanutin
Dosage Form : To concentrate the Injection/infusion fluid, resolution
Dosage Strength : 50 FNE mg/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Pro-Epanutin
Dosage Form : Concentrate for injection/infusion solution, solution
Dosage Strength : 75 mg/ml
Packaging : Vials 10 10ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Approved
Registration Country : Sweden
Fosphenytoin Sodium (Anhydrous)
Brand Name : Pro-Epanutin
Dosage Form : Concentrate For Solution For Infusion Or Injection
Dosage Strength : 75mg/ml
Packaging :
Approval Date : 25/09/1998
Application Number : 19980925000072
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Fosphenytoin Sodium Heptahydrate
Brand Name : Fosphenytoin Frost
Dosage Form : Injectable Solution
Dosage Strength : 75mg/ml
Packaging :
Approval Date : 23/11/2022
Application Number : 20220401000124
Regulatory Info : Approved
Registration Country : Sweden
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