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SUBUTEX FDT buprenorphine 8 mg (as hydrochloride) tablet blister pack - TGA Drug Approval Details
Approvals
/
TGA
/
SUBUTEX FDT buprenorphine 8 mg (as hydrochloride) tablet blister pack
Approved
STANDARD
SUBUTEX FDT buprenorphine 8 mg (as hydrochloride) tablet blister pack
Indivior Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
3b3449e1640f2ca9
Company
Indivior Pty Ltd
Type
Standard
Approval Details
Approval Id
3b3449e1640f2ca9
Product Name
SUBUTEX FDT buprenorphine 8 mg (as hydrochloride) tablet blister pack
Artg Id
134405
Artg Name
SUBUTEX FDT buprenorphine 8 mg (as hydrochloride) tablet blister pack
Sponsor
Indivior Pty Ltd
Company Detail Path
/organization/indivior-pty-ltd
Artg Date
2007-10-31
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
3b3449e1640f2ca9
Type
Standard
Back to TGA Approvals