Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Name of policy document:

ARM 62: Lamisil Once 1% Cutaneous Solution - Request to Reclassify a Product from P to GSL

Deadline for response:

6 July 2009

Background: Lamisil Once is a line extension of the well-established cream formulation of the anti-fungal drug terbinafine. This latest development which is a film forming solution requiring a one-off application of the product, has been available as a pharmacy only (P) medicine for the treatment of Athlete’s Foot since November 2005. Active ingredients: Terbinafine hydrochloride (1% w/w). Indications: Treatment for tinea pedis (athlete’s foot).

Download this consultation response as a .pdf

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939

[6 July 2009]