We approach our work with compassion for people living with opioid use disorder and deep respect for their families and communities, delivering high-quality treatments that reflect this responsibility in every decision we make.
We foster a culture of innovation and accountability, underpinned by robust systems, structures, and strategies that embed safety into every aspect of our operations. From rigorous product development to continuous post-market surveillance, our frameworks ensure that every medicine we provide meets the highest standards of safety and quality – helping people living with OUD trust the medical treatments they receive.
Our pharmacovigilance management system is continuously strengthened through close collaboration with manufacturing partners and adherence to global regulatory requirements. In the United States, this includes FDA-mandated Risk Evaluation and Mitigation Strategies (REMS):
For sublingual SUBOXONE® film, REMS help reduce the risks of accidental overdose, misuse, and abuse, while providing essential safety information to healthcare professionals and people with OUD.
For SUBLOCADE®, REMS help mitigate the risk of serious harm or death that could result from intravenous self-administration, requiring that SUBLOCADE be dispensed to and administered by an HCP.
In all markets where we operate, we proactively evolve our product risk management plans to ensure that the people we serve have confidence in the safety, efficacy, and quality of our medical treatments.
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