Approvals/TGA/SUBLOCADE buprenorphine 300 mg/1.5 mL modified release solution for injection pre-filled syringe (with needle)

Approved

STANDARD

SUBLOCADE buprenorphine 300 mg/1.5 mL modified release solution for injection pre-filled syringe (with needle)

Indivior Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 4625286d35ad9ac0
Product Name: SUBLOCADE buprenorphine 300 mg/1.5 mL modified release solution for injection pre-filled syringe (with needle)
Artg Id: 303753
Artg Name: SUBLOCADE buprenorphine 300 mg/1.5 mL modified release solution for injection pre-filled syringe (with needle)
Sponsor: Indivior Pty Ltd
Company Detail Path: /organization/indivior-pty-ltd
Artg Date: 2019-07-18
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-2020-CMI-01182-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2019-PI-01756-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

4625286d35ad9ac0

Type

Standard