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PALYNZIQ pegvaliase 2.5 mg/0.5 mL solution for injection pre-filled syringe - TGA Drug Approval Details
Approvals
/
TGA
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PALYNZIQ pegvaliase 2.5 mg/0.5 mL solution for injection pre-filled syringe
Approved
STANDARD
PALYNZIQ pegvaliase 2.5 mg/0.5 mL solution for injection pre-filled syringe
BioMarin Pharmaceutical Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
f0a1da443d8a46ec
Company
BioMarin Pharmaceutical Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
f0a1da443d8a46ec
Product Name
PALYNZIQ pegvaliase 2.5 mg/0.5 mL solution for injection pre-filled syringe
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
Company Detail Path
/organization/biomarin-pharmaceutical-australia-pty-ltd
Artg Date
2021-07-14
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021-CMI-01919-1
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021-PI-01918-1
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
f0a1da443d8a46ec
Type
Standard
Back to TGA Approvals