Advert - Otsuka Europe and Otsuka UK

• Date posted
  01 February 2021
• Sanction
  Advertisement,
• Case number/s
  AUTH/3219/6/19 and AUTH/3220/6/19 - Voluntary admission from Otsuka Europe and Otsuka UK

Otsuka Europe and Otsuka UK voluntarily admitted omissions and errors in the prescribing information for four of its medicines and breaches of undertakings given in relation to previous cases and were ruled in breach of the following clauses of the Code in relation to Samsca (tolvaptan):

Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

Clause 4.1 - Failing to have up-to-date prescribing information

Clause 9.1 - Failing to maintain high standards

Clause 29 - Failing to comply with an undertaking