Neutrogena T/Gel Therapeutic Shampoo - Public Assessment Report (PAR)
Published 19 October 2022
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This publication is available at https://www.gov.uk/government/publications/public-assessment-report-for-the-reclassification-of-neutrogena-tgel-therapeutic-shampoo/neutrogena-tgel-therapeutic-shampoo-public-assessment-report-par
On 2 August 2022, the MHRA granted a request by the marketing authorisation holder Johnson & Johnson Limited to increase the maximum pack size of Neutrogena T/Gel Therapeutic Shampoo (PL 08874/0014) as a general sale list (GSL) medicine to 500ml (in 2x250ml combination pack).
Neutrogena T/Gel Therapeutic Shampoo contains the active ingredient solubilised coal tar extract 20mg/ml (equivalent to 5mg/ml coal tar).
The request to increase the pack size for Neutrogena T/Gel Therapeutic Shampoo was assessed against the GSL criterion. No new or unexpected safety concerns arose from this request, and it was therefore deemed that the benefits of having Neutrogena T/Gel Therapeutic Shampoo available in larger pack sizes for treatment for seborrhoeic dermatitis of the scalp, dandruff and scalp psoriasis outweigh the risks.
The maximum pack size for Neutrogena T/Gel Therapeutic Shampoo as a GSL medicine is now 500ml (in 2x250ml combination pack). There are no other changes to the conditions for this product as a GSL medicine.