MedPath
HSA Approval

SOOLANTRA CREAM 10MG/G

SIN15197P

SOOLANTRA CREAM 10MG/G

SOOLANTRA CREAM 10MG/G

March 23, 2017

GALDERMA SINGAPORE PRIVATE LIMITED

GALDERMA SINGAPORE PRIVATE LIMITED

Regulatory Information

GALDERMA SINGAPORE PRIVATE LIMITED

GALDERMA SINGAPORE PRIVATE LIMITED

Therapeutic

Prescription Only

Formulation Information

CREAM

**4.2 Posology and method of administration** Posology One application a day for up to 4 months. Soolantra should be applied daily over the treatment course. The treatment course may be repeated. In case of no improvement after 3 months, the treatment should be discontinued. _Special population_ _Renal impairment_ No dosage adjustment is necessary. _Hepatic impairment_ Caution should be exercised in patients with severe hepatic impairment. _Elderly patients_ No dosage adjustment is necessary in the geriatric population (see also section 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ The safety and efficacy of Soolantra in children and adolescents aged less than 18 years have not been established. No data are available. Method of administration Cutaneous use only. Cutaneous application of a pea-size amount of medicinal product to each of the five areas of the face: forehead, chin, nose, and each cheek. The medicinal product should be spread as a thin layer across the entire face, avoiding the eyes, lips and mucosa. Soolantra should be applied only to the face. Hands should be washed after applying the medicinal product. Cosmetics may be applied after the medicinal product has dried.

TOPICAL

Medical Information

**4.1 Therapeutic indications** Soolantra is indicated for the topical treatment of inflammatory lesions of rosacea (papulopustular) in adult patients.

**4.3 Contraindications** Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.

D11AX22

ivermectin

Manufacturer Information

GALDERMA SINGAPORE PRIVATE LIMITED

LABORATOIRES GALDERMA

Active Ingredients

IVERMECTIN

10 mg/g

Ivermectin

Documents

Package Inserts

Soolantra Cream PI.pdf

Approved: June 8, 2020

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