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HSA Approval

DAIVOBET OINTMENT

SIN12241P

DAIVOBET OINTMENT

DAIVOBET OINTMENT

March 27, 2003

DKSH SINGAPORE PTE. LTD.

DKSH SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantDKSH SINGAPORE PTE. LTD.
Licence HolderDKSH SINGAPORE PTE. LTD.

Product Classification

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

Formulation Information

OINTMENT

**Posology and method of administration** Posology Daivobet® Ointment should be applied to the affected area once daily. The recommended treatment period is 4 weeks. There is experience with repeated courses of Daivobet® Ointment up to 52 weeks. If it is necessary to continue or restart treatment after 4 weeks, treatment should be continued after medical review and under regular medical supervision. When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g, the maximum weekly dose should not exceed 100 g, and the body surface area treated with calcipotriol containing medicinal products should not exceed 30%. Special Populations _Renal and hepatic impairment_ The safety and efficacy of Daivobet® Ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. Paediatric population The safety and efficacy of Daivobet® Ointment in children below 18 years have not been established. Currently available data in children aged 12 to 17 years are described in sections "Undesirable effects and Pharmacodynamics properties" – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_, but no recommendation on a posology can be made. Method of Administration Daivobet® Ointment should be applied to the affected area. In order to achieve optimal effect, it is not recommended to take a shower or bath immediately after application of Daivobet® Ointment.

TOPICAL

Medical Information

**Indications** Initial topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy.

**Contraindications** Hypersensitivity to the active substances or to any of the excipients. Due to the content of calcipotriol, Daivobet® Ointment is contraindicated in patients with known disorders of calcium metabolism. Due to the content of corticosteroid, Daivobet® Ointment is contraindicated in the following conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers, wounds and perianal and genital pruritus. Daivobet® is contraindicated in erythrodermic, exfoliative and pustular psoriasis.

D05AX52

calcipotriol, combinations

Manufacturer Information

DKSH SINGAPORE PTE. LTD.

LEO LABORATORIES LIMITED

Active Ingredients

Calcipotriol monohydrate 52.2 mcg/g eqv calcipotriol

50 mcg/g

Calcipotriol

Betamethasone dipropionate 0.643mg/g eqv betamethasone

0.5 mg/g

Betamethasone

Documents

Package Inserts

Daivobet Ointment_PI.pdf

Approved: October 9, 2019

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DAIVOBET OINTMENT - HSA Approval | MedPath