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SUBOXONE FILM 8/2 buprenorphine (as hydrochloride) 8 mg/naloxone (as hydrochloride dihydrate) 2 mg soluble film sachet - TGA Drug Approval Details
Approvals
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TGA
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SUBOXONE FILM 8/2 buprenorphine (as hydrochloride) 8 mg/naloxone (as hydrochloride dihydrate) 2 mg soluble film sachet
Approved
STANDARD
SUBOXONE FILM 8/2 buprenorphine (as hydrochloride) 8 mg/naloxone (as hydrochloride dihydrate) 2 mg soluble film sachet
Indivior Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 29, 2025
Approval ID
23f9bd8260dfec01
Company
Indivior Pty Ltd
Type
Standard
Approval Details
Approval Id
23f9bd8260dfec01
Product Name
SUBOXONE FILM 8/2 buprenorphine (as hydrochloride) 8 mg/naloxone (as hydrochloride dihydrate) 2 mg soluble film sachet
Artg Id
163444
Artg Name
SUBOXONE FILM 8/2 buprenorphine (as hydrochloride) 8 mg/naloxone (as hydrochloride dihydrate) 2 mg soluble film sachet
Sponsor
Indivior Pty Ltd
Company Detail Path
/organization/indivior-pty-ltd
Artg Date
2011-02-18
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/f2fbe2142ea59ae44935901b6cc9ca14.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/772be6ea9f21742f9f972d4e22f14bd1.pdf
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 29, 2025
Approval ID
23f9bd8260dfec01
Type
Standard
Back to TGA Approvals