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APO-AGOMELATINE agomelatine (as agomelatine-citric acid) 25 mg film-coated tablet blister pack - TGA Drug Approval Details
Approvals
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TGA
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APO-AGOMELATINE agomelatine (as agomelatine-citric acid) 25 mg film-coated tablet blister pack
Approved
STANDARD
APO-AGOMELATINE agomelatine (as agomelatine-citric acid) 25 mg film-coated tablet blister pack
Southern Cross Pharma Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
f40438419dfc942f
Company
Southern Cross Pharma Pty Ltd
Type
Standard
Approval Details
Approval Id
f40438419dfc942f
Product Name
APO-AGOMELATINE agomelatine (as agomelatine-citric acid) 25 mg film-coated tablet blister pack
Artg Id
318686
Artg Name
APO-AGOMELATINE agomelatine (as agomelatine-citric acid) 25 mg film-coated tablet blister pack
Sponsor
Southern Cross Pharma Pty Ltd
Company Detail Path
/organization/southern-cross-pharma-pty-ltd
Artg Date
2020-06-26
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
f40438419dfc942f
Type
Standard
Back to TGA Approvals