Advert - Otsuka Europe – Case AUTH/3489/3/21

Communication of revision of Samsca summary of product characteristics


For voluntarily admitting a failure to promptly notify affiliates of changes to the summary of product characteristics for Samsca (tolvaptan) and to promptly provide the updated prescribing information which meant that it had breached the undertaking given in a previous case, Otsuka Europe was ruled in breach of the following clauses of the 2019 Code:

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 9.1 - Failing to maintain high standards
Clause 29 - Failing to comply with an undertaking