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01 1Amifampridine
02 2CERLIPONASE ALFA
03 1Cerliponase Alpha
04 2ELOSULFASE ALFA
05 1Elosulfase Alpha
06 1GALSULFASE
07 1Galsulfase
08 1LARONIDASE
09 3PEGVALIASE
10 3PEGVALIASE-PQPZ
11 3Pegvaliase
12 5SAPROPTERIN DIHYDROCHLORIDE
13 13Sapropterin
14 1Sapropterin Dihydrochloride
15 1Sapropterina
16 3VOSORITIDE
17 1Valoctocogen Roxaparvovec
18 3Vosoritide
19 3vosoritide
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01 2BIOMARIN
02 9BIOMARIN INTERNATIONAL LIMITED
03 11BIOMARIN PHARM
04 1BioMarin Europe Limited
05 1BioMarin International Limited
06 14BioMarin Pharmaceutical Australia Pty Ltd
07 11Biomarin International Limited
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01 1Antic-calc Tablet
02 2Concentrate For Infusion Solution
03 1INJECTABLE; INJECTION
04 5INJECTABLE;INJECTION
05 3Injectable Solution In Pre-Filled Syringe
06 1POWDER
07 2POWDER;ORAL
08 3POWDER;SUBCUTANEOUS
09 3Powder And Solvent For Injectable Solution
10 5SOLUTION
11 1Soluble Antic-Calc tablet
12 1Soluble Tablet
13 2Soluble Tablets
14 1Solution
15 1Solution For Perfusion
16 1TABLET
17 1TABLET;ORAL
18 1VIAL
19 14Blank
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01 10.4MG
02 10.4MG/VIAL
03 10.56MG
04 10.56MG/VIAL
05 11.2MG
06 11.2MG/VIAL
07 110 mg
08 1100 mg
09 3100MG
10 1100MG/PACKET
11 1100MG/SACHET
12 2100mg
13 110MG
14 210MG/0.5ML
15 1150MG
16 1150MG/5ML
17 21MG
18 11MG/ML
19 12.5MG
20 12.5MG/0.5ML
21 12.5MG/O.5ML
22 12.9MG/ML
23 120MG
24 220MG/ML
25 130MG/ML
26 1500MG/PACKET
27 25MG/5ML
28 15Blank
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01 14Australia
02 7Canada
03 2Italy
04 2Norway
05 11Spain
06 13USA
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet
Brand Name : Firdapse
Dosage Strength : 10 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : BRINEURA
Dosage Strength : 30MG/ML
Packaging :
Approval Date :
Application Number : 761052
Regulatory Info :
Registration Country : USA
Regulatory Info : Schedule D
Registration Country : Canada
Dosage Form : SOLUTION
Brand Name : BRINEURA
Dosage Strength : 150MG/5ML
Packaging :
Approval Date :
Application Number : 2484013
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Solution For Perfusion
Brand Name : Brineura
Dosage Strength : 150MG
Packaging :
Approval Date : 2019-06-21
Application Number : 1171192001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info :
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : VIMIZIM
Dosage Strength : 5MG/5ML
Packaging :
Approval Date :
Application Number : 125460
Regulatory Info :
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
Dosage Form : SOLUTION
Brand Name : VIMIZIM
Dosage Strength : 1MG/ML
Packaging : 5ML
Approval Date :
Application Number : 2427184
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Concentrate For Infusion...
Brand Name : Vimizim
Dosage Strength : 1MG
Packaging :
Approval Date : 2015-03-23
Application Number : 114914001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info :
Registration Country : USA
Dosage Form : INJECTABLE; INJECTION
Brand Name : NAGLAZYME
Dosage Strength : 5MG/5ML
Packaging :
Approval Date :
Application Number : 125117
Regulatory Info :
Registration Country : USA
Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Concentrate For Infusion...
Brand Name : Naglazyme
Dosage Strength : 1MG
Packaging :
Approval Date : 2006-06-19
Application Number : 05324001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info :
Registration Country : USA
Dosage Form : VIAL
Brand Name : ALDURAZYME
Dosage Strength : 2.9MG/ML
Packaging :
Approval Date :
Application Number : 125058
Regulatory Info :
Registration Country : USA