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HSA Approval

CLOBEX SPRAY 0.05% w/w

SIN15185P

CLOBEX SPRAY 0.05% w/w

CLOBEX SPRAY 0.05% w/w

February 28, 2017

GALDERMA SINGAPORE PRIVATE LIMITED

GALDERMA SINGAPORE PRIVATE LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGALDERMA SINGAPORE PRIVATE LIMITED
Licence HolderGALDERMA SINGAPORE PRIVATE LIMITED

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

SOLUTION

**Posology / method of administration** Clobex cutaneous spray is intended for use on the skin, the solution should be sprayed directly onto the affected areas twice daily and then rubbed in gently until completely absorbed. Hands should be washed carefully after application. Each cycle of treatment should be limited to 4 consecutive weeks. Treatment of a lesion has to be stopped as soon as disease control is achieved; the diagnostic is to be re-evaluated if there is no improvement observed after 2 weeks. Not more than 50g of spray-solution should be used per week. No more than 35 sprays should be involved in one application, i.e. not more than 70 sprays per day. Clobetasol propionate belongs to the most potent class of topical corticosteroids (class IV/class I) and prolonged use may result in serious undesirable effects (see Warnings and Precautions). If treatment with a local corticosteroid is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered. Repeated but short courses of clobetasol propionate may be used to control exacerbations. Clobex cutaneous spray should be used neither on the face nor on intertriginous areas (axillae and genitoanal regions, see “Warnings and precautions” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The safety and efficacy of Clobex cutaneous spray in children and adolescents under 18 years of age have not been established so far. No data are available in this context.

CUTANEOUS

Medical Information

**Indications / possibilities of use** Topical treatment of moderate to severe plaque-type psoriasis, from 18 years of age on.

**Contra-indications** Clobetasol propionate is contraindicated in patients who are hypersensitive to Clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation. Skin areas affected by bacterial and mycobacterial, viral, fungal, parasitic infections or ulcerous wounds. Must not be used in Children under 2 years of age Must not be applied to the eyes and eyelids (risk of glaucoma, risk of cataract).

D07AD01

clobetasol

Manufacturer Information

GALDERMA SINGAPORE PRIVATE LIMITED

LABORATOIRES GALDERMA

Active Ingredients

CLOBETASOL PROPIONATE 0.05%

0.05% w/w

Clobetasol propionate

Documents

Package Inserts

Clobex Spray PI.pdf

Approved: January 17, 2023

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