FOI release

Difflam Oral Spray - Posology and legal classification

Some or all of the information requested was not provided because we didn't hold it.

Case reference FOI2026/00375

Received 7 April 2026

Published 12 May 2026

Request

I would like to submit freedom of information request in relation to 'Difflam 0.15% w/v Spray'. I would like to know the date of approval when the age ranges '2 to 6 years' and '6 to 12 years' were added to the original license. I would like a copy of the assessment report for this variation. I would like a copy of the clinical overview for this application. I would like to if the legal classification (pharmacy only) has changed (or not) since the original MA grant on 30 November 1984, dates of approval, and any assessment reports / public consultations that were carried out as part of any changes to the legal classification.

Response

See attached

Documents

• FOI2026_00375 (redacted).pdf (811.5 KB)

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