TGA Approval

PALYNZIQ pegvaliase 2.5 mg/0.5 mL solution for injection pre-filled syringe (341753)

ARTG ID

341753

ARTG Name

PALYNZIQ pegvaliase 2.5 mg/0.5 mL solution for injection pre-filled syringe

Sponsor

BioMarin Pharmaceutical Australia Pty Ltd

ARTG Date

July 14, 2021

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-2021-CMI-01919-1

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021-PI-01918-1

Ingredient Name

pegvaliase

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PALYNZIQ pegvaliase 2.5 mg/0.5 mL solution for injection pre-filled syringe (341753) - TGA 批准文号 | MedPath