SmPC - ClobaDerm® 500 micrograms/g Cream / Clobetasol Propionate 500 micrograms/g Cream: Change history

To register update to section 4.4 of SPC in line with MHRA request to add potency information to the labelling of topical corticosteroids. Consequently, the PIL and labelling has been updated.

Description of update: To change the name of the medicinal product in the UK from 'ClobaDerm® 500 micrograms/g Cream' to 'ClobaDerm® 500 micrograms/g Cream, Clobetasol Propionate 500 micrograms/g Cream'. Consequently, sections 1, 2, 4.1, 4.2, 4.3, 4.4, 4.6, 4.7, 4.9, 6.2, 6.6 of the SPC, the PIL and label have been updated.

SmPC sections updated: 1, 2, 4.1, 4.2, 4.3, 4.4, 4.6, 4.7, 4.9, 6.2, 6.6 and 10.

Initial upload