Wyeth Consumer Healthcare has notified the EMEA of its decision to withdraw its application for a centralised marketing authorisation for ibuprofen/diphenhydramine hydrochloride 200mg/25mg soft capsules, intended for use in the short-term treatment of mild to moderate pain in adults who experience sleeplessness as a result of the pain.

According to its official letter, the application was withdrawn based on the CHMP’s view that the data provided would not allow a positive risk-benefit balance to be concluded. 

A question-and-answer document and the withdrawal letter from the company will be published on the EMEA website in the near future.