Advert - Otsuka Pharmaceutical Europe Limited - Case AUTH/3565/10/21 and Otsuka Pharmaceuticals (UK) Limited - Case AUTH/3566/10/21

• Date posted
  21 June 2022
• Sanction
  Advertisement,
• Case number/s
  AUTH/3565/10/21 and AUTH/3566/10/21 - Voluntary admission by Otsuka Europe and Otsuka UK

For omitting the frequency of dosing from prescribing information for a monthly administration of Abilify/Abilify Maintena (aripiprazole) and for breaching previous undertakings Otsuka Europe and Otsuka UK were each 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