Approvals/TGA/SUBOXONE FILM 12/3 buprenorphine (as hydrochloride) 12 mg naloxone (as hydrochloride dihydrate) 3 mg soluble film sachet

Approved

STANDARD

SUBOXONE FILM 12/3 buprenorphine (as hydrochloride) 12 mg naloxone (as hydrochloride dihydrate) 3 mg soluble film sachet

Indivior Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 0a70a0dbe8b47ac5
Product Name: SUBOXONE FILM 12/3 buprenorphine (as hydrochloride) 12 mg naloxone (as hydrochloride dihydrate) 3 mg soluble film sachet
Artg Id: 211120
Artg Name: SUBOXONE FILM 12/3 buprenorphine (as hydrochloride) 12 mg/naloxone (as hydrochloride dihydrate) 3 mg soluble film sachet
Sponsor: Indivior Pty Ltd
Company Detail Path: /organization/indivior-pty-ltd
Artg Date: 2014-05-20
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Product Information: https://medical-cdn.nocode.com/drug_tga/772be6ea9f21742f9f972d4e22f14bd1.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

0a70a0dbe8b47ac5

Type

Standard