Advert - Lundbeck – Case AUTH/3452/1/21

Promotion of Abilify


For an article which promoted Abilify Maintena (aripiprazole) in a manner which was not in accordance with its marketing authorisation, used inaccurate efficacy and safety claims which were not capable of substantiation, did not include prescribing information and other mandatory information and was considered to be disguised promotion, Lundbeck 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 3.2 - Promotion inconsistent with the summary of product characteristics
Clause 4.1 - Failing to include up-to-date prescribing information
Clause 4.6 - Failing to include a clear, prominent statement as to where
prescribing information could be found
Clause 4.9 - Failing to include information about how to report adverse events
Clause 7.2 - Making a misleading claim
Clause 7.4 - Making an unsubstantiated claim
Clause 7.9 - Making claims that did not reflect the available evidence regarding possible adverse reactions
Clause 9.1 - Failing to maintain high standards
Clause 12.1 - Disguising promotional material