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ROACCUTANE isotretinoin 20mg capsule - TGA Drug Approval Details
Approvals
/
TGA
/
ROACCUTANE isotretinoin 20mg capsule
Approved
STANDARD
ROACCUTANE isotretinoin 20mg capsule
Pharmaco Australia Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
95cf541dbfc50324
Company
Pharmaco Australia Ltd
Type
Standard
Approval Details
Approval Id
95cf541dbfc50324
Product Name
ROACCUTANE isotretinoin 20mg capsule
Artg Id
50839
Artg Name
ROACCUTANE isotretinoin 20mg capsule blister pack
Sponsor
Pharmaco Australia Ltd
Artg Date
1994-12-13
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-2010-CMI-03466-3
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-01746-3
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
95cf541dbfc50324
Type
Standard
Back to TGA Approvals