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 FOI2026/00376

Received 7 April 2026

Published 12 May 2026

Request

Please provide any internal scientific assessment reports, assessor summaries, or committee briefing documents held by MHRA relating to the assessment and approval of Difflam 0.15% w/v Spray, authorised 30 November 1984 in relation to: - Variation to add the age ranges '2 to 6 years' and '6 to 12 years' to the posology. - Changes to the legal classification of this product since MA grant. If full disclosure is not possible, please provide confirmation of the existence of such documents and the exemptions relied upon.

Response

See attached

Documents

• FOI2026_00376 (redacted).pdf (811.5 KB)

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