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ARX-Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets composite blister pack - TGA Drug Approval Details
Approvals
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TGA
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ARX-Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets composite blister pack
Approved
STANDARD
ARX-Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets composite blister pack
Arrotex Pharmaceuticals Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 30, 2025
Approval ID
3913c940f9947db7
Company
Arrotex Pharmaceuticals Pty Ltd
Type
Standard
Approval Details
Approval Id
3913c940f9947db7
Product Name
ARX-Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets composite blister pack
Artg Id
393495
Artg Name
ARX-Varenicline 0.5 mg varenicline (as tartrate) tablets and 1.0 mg varenicline (as tartrate) tablets composite blister pack
Sponsor
Arrotex Pharmaceuticals Pty Ltd
Company Detail Path
/organization/arrotex-pharmaceuticals-pty-ltd
Artg Date
2022-11-24
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 30, 2025
Approval ID
3913c940f9947db7
Type
Standard
Back to TGA Approvals
