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NLS mundipharma

Regulatory compliance - October 3, 2016

Orexo announce EU regulatory submission

Mundipharma and Orexo have announced the submission of a regulatory submission of a Marketing Authorisation Application (MAA) for Zubsolv (buprenorphine and naloxone) sublingual tablet to the European Medicines Agency (EMA), seeking approval for the treatment of opioid dependence. If approval is received, the buprenorphine and naloxone sublingual tablet would be the first fast dissolving buprenorphine […]

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