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HSA Approval

DAIVONEX OINTMENT 50 mcg/g

SIN06587P

DAIVONEX OINTMENT 50 mcg/g

DAIVONEX OINTMENT 50 mcg/g

September 26, 1991

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

**Dosage and administration** **Adults:** Daivonex® ointment should be applied to the affected area twice daily. For some patients adequate maintenance therapy may be achieved with less frequent application. The maximum amount used by an adult in one week should not exceed 100 g (equivalent to 5 mg of calcipotriol). If using other calcipotriol containing medicinal products concomitantly, the total weekly dose of all calcipotriol containing medical products, including Daivonex® ointment, should not exceed 5 mg of calcipotriol.

TOPICAL

Medical Information

**Indications** Psoriasis vulgaris.

**Contraindications** Hypersensitivity to the active substance or to any of the excipients. Due to the content of calcipotriol, Daivonex® ointment is contraindicated in patients with known disorders of calcium metabolism (see Special warnings and precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

D05AX02

calcipotriol

Manufacturer Information

DKSH SINGAPORE PTE. LTD.

LEO LABORATORIES LIMITED

Active Ingredients

CALCIPOTRIOL

50 mcg/g

Calcipotriol

Documents

Package Inserts

Daivonex ointment PI.pdf

Approved: August 26, 2019

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