Pre-licence promotion and breach of undertaking
Date posted01 February 2021
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