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OMACOR (omega-3-acid ethyl esters 90) 1000 mg soft capsule bottle - TGA Drug Approval Details
Approvals
/
TGA
/
OMACOR (omega-3-acid ethyl esters 90) 1000 mg soft capsule bottle
Approved
STANDARD
OMACOR (omega-3-acid ethyl esters 90) 1000 mg soft capsule bottle
Arrotex Pharmaceuticals Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
c6f1ee61c031f9da
Company
Arrotex Pharmaceuticals Pty Ltd
Type
Standard
Approval Details
Approval Id
c6f1ee61c031f9da
Product Name
OMACOR (omega-3-acid ethyl esters 90) 1000 mg soft capsule bottle
Artg Id
155717
Artg Name
OMACOR (omega-3-acid ethyl esters 90) 1000 mg soft capsule bottle
Sponsor
Arrotex Pharmaceuticals Pty Ltd
Company Detail Path
/organization/arrotex-pharmaceuticals-pty-ltd
Artg Date
2010-08-05
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-2025-CMI-01204-1
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2025-PI-01203-1
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
c6f1ee61c031f9da
Type
Standard
Back to TGA Approvals