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01 1Farmak JSC
02 2ORPHAN EUROPE
03 1RECORDATI RARE DISEASES SARL
04 2Recordati Rare Diseases
05 1SERB SA
06 2Serb Sa
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01 2Anhydrous Betaine
02 1Arginine citrate; Betaine Hydrochloride; Betaine
03 6Betaine
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01 1Betaine 180G 1 Combined Oral Use
02 4Oral Powder
03 2Oral Powder Oral Use
04 1Powder
05 1Solution
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01 3Italy
02 1Norway
03 2Spain
04 2Sweden
05 1Ukraine
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01 1AMVERSIO
02 2Amversio
03 1CYSTADANE
04 4Cystadane
05 1Hepargin
Regulatory Info :
Registration Country : Ukraine
Arginine citrate; Betaine Hydrochloride; Betaine
Brand Name : Hepargin
Dosage Form : Solution
Dosage Strength :
Packaging : 10ML Glass Vial
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info :
Registration Country : Italy
Brand Name : Cystadane
Dosage Form : Betaine 180G 1 Combined Oral Use
Dosage Strength : 1 vial OS 180 g + 3 tablespoons
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Cystadane
Dosage Form : Powder
Dosage Strength : 1 g
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Brand Name : CYSTADANE
Dosage Form : Oral Powder Oral Use
Dosage Strength : 1 g
Packaging : 1 UNIT 180 G - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Cystadane
Dosage Form : Oral Powder
Dosage Strength : 1g
Packaging :
Approval Date : 15/02/2007
Application Number : 20060112000248
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Cystadane
Dosage Form : Oral Powder
Dosage Strength : 1G
Packaging :
Approval Date : 2007-04-25
Application Number : 06379001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info :
Registration Country : Italy
Brand Name : AMVERSIO
Dosage Form : Oral Powder Oral Use
Dosage Strength : 1 g
Packaging : 1 UNIT 180 G - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Amversio
Dosage Form : Oral Powder
Dosage Strength : 1g
Packaging :
Approval Date : 06/05/2022
Application Number : 20201110000018
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Amversio
Dosage Form : Oral Powder
Dosage Strength : 1G
Packaging :
Approval Date : 2024-06-24
Application Number : 1221640001
Regulatory Info : Authorized
Registration Country : Spain