TGA Approval

KUVAN sapropterin dihydrochloride 100 mg oral powder sachet (297728)

ARTG ID

297728

ARTG Name

KUVAN sapropterin dihydrochloride 100 mg oral powder sachet

Sponsor

BioMarin Pharmaceutical Australia Pty Ltd

ARTG Date

December 13, 2018

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

BIOMARIN PHARMACEUTICAL AUSTRALIA PTY LTD

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2016-CMI-01941-1

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2018-PI-02719-1

Ingredient Name

sapropterin dihydrochloride

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KUVAN sapropterin dihydrochloride 100 mg oral powder sachet (297728) - TGA 批准文号 | MedPath