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VARENIX varenicline (as tartrate) 0.5 mg and varenicline (as tartrate) 1 mg film coated tablet composite blister pack - TGA Drug Approval Details
Approvals
/
TGA
/
VARENIX varenicline (as tartrate) 0.5 mg and varenicline (as tartrate) 1 mg film coated tablet composite blister pack
Approved
STANDARD
VARENIX varenicline (as tartrate) 0.5 mg and varenicline (as tartrate) 1 mg film coated tablet composite blister pack
Pharmacor Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
5e3cbcf516de7633
Company
Pharmacor Pty Ltd
Type
Standard
Approval Details
Approval Id
5e3cbcf516de7633
Product Name
VARENIX varenicline (as tartrate) 0.5 mg and varenicline (as tartrate) 1 mg film coated tablet composite blister pack
Artg Id
395131
Artg Name
VARENIX varenicline (as tartrate) 0.5 mg and varenicline (as tartrate) 1 mg film coated tablet composite blister pack
Sponsor
Pharmacor Pty Ltd
Company Detail Path
/organization/pharmacor-sa-pty-ltd
Artg Date
2023-08-17
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-2023-CMI-02124-1
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-PI-02126-1
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
5e3cbcf516de7633
Type
Standard
Back to TGA Approvals