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Pre-licence promotion and breach of undertaking
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Date posted01 February 2021
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SanctionAdvertisement,
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Case number/s
For promoting Tremfya (guselkumab) for an unlicensed indication and failing to comply with its previous undertaking, Janssen was ruled in breach of the following clauses of the Code.
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 3.2 - Promoting a medicine for an unlicensed indication
Clause 9.1 - Failing to maintain high standards
Clause 29 - Failing to comply with an undertaking