EMA. Summary of opinion (post authorisation): Suboxone (buprenorphine / naloxone) sublingual film
EMA. Summary of opinion (post authorisation): Suboxone (buprenorphine / naloxone) sublingual film
On 30 April 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Suboxone. The marketing authorisation holder for this medicinal product is Indivior Europe Limited.
The CHMP adopted a new pharmaceutical form (sublingual film) associated with four new strengths (2/0.5, 4/1, 8/2, and 16/4 mg) for either sublingual or buccal use. The new formulation adds additional safety features to prevent intravenous misuse. (EMA - European Medicines Agency, Amsterdam, 30 April 2020, EMA/CHMP/219873/2020, Committee for Medicinal Products for Human Use (CHMP)
https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-suboxone-x-42_en.pdf