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PRALUENT alirocumab (rch) 75mg/mL, solution for injection, pre-filled pen - TGA Drug Approval Details
Approvals
/
TGA
/
PRALUENT alirocumab (rch) 75mg/mL, solution for injection, pre-filled pen
Approved
STANDARD
PRALUENT alirocumab (rch) 75mg/mL, solution for injection, pre-filled pen
Sanofi-Aventis Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
eb7c26f6930fe8d7
Company
Sanofi-Aventis Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
eb7c26f6930fe8d7
Product Name
PRALUENT alirocumab (rch) 75mg/mL, solution for injection, pre-filled pen
Artg Id
238285
Artg Name
PRALUENT alirocumab (rch) 75mg/mL solution for injection, pre-filled pen
Sponsor
Sanofi-Aventis Australia Pty Ltd
Company Detail Path
/organization/sanofi-aventis-australia-pty-ltd
Artg Date
2016-05-17
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-2016-CMI-01965-1
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2015-PI-01366-1
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
eb7c26f6930fe8d7
Type
Standard
Back to TGA Approvals