TGA approves key label updates to Buvidal for treatment of opioid dependence

Camurus

3 May 2021 - Camurus today announced that the Australian regulatory agency, the TGA, has approved key label updates to Buvidal Weekly and Buvidal Monthly (buprenorphine) modified-release solutions for injection.

The approval includes:

  • A new higher Buvidal Monthly 160 mg dose
  • Direct initiation onto Buvidal Weekly, removing the requirement to be stabilised on sublingual buprenorphine prior to commencing treatment with Buvidal
  • Changing the contraindications in pregnancy and lactation to precautions

Camurus will now initiate the process for reimbursement for the 160 mg dose through the Pharmaceutical Benefits Advisory Committee process.

Read Camurus press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Outcome , Medicine , Australia