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HSA Approval

PROPECIA TABLET 1 mg

SIN09921P

PROPECIA TABLET 1 mg

PROPECIA TABLET 1 mg

July 31, 1998

ORGANON SINGAPORE PTE. LTD.

ORGANON SINGAPORE PTE. LTD.

Regulatory Information

ORGANON SINGAPORE PTE. LTD.

ORGANON SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

TABLET, FILM COATED

**III. DOSAGE AND ADMINISTRATION** The recommended dosage is one 1-mg tablet daily. PROPECIA may be taken with or without food. In general, daily use for 3 months or more is necessary before increased hair growth and/or prevention of further hair loss is observed. Continued use is recommended to obtain maximum benefit. Withdrawal of treatment leads to reversibility of effect within 12 months.

ORAL

Medical Information

**II. INDICATIONS** PROPECIA is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss. PROPECIA is **not** indicated for use in women (see PREGNANCY and _Studies in women_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) or children.

**V. CONTRAINDICATIONS** PROPECIA is contraindicated in the following: - Use in women when they are or may potentially be pregnant (see PREGNANCY – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Hypersensitivity to any component of this product PROPECIA is not indicated for use in women or children.

D11AX10

finasteride

Manufacturer Information

ORGANON SINGAPORE PTE. LTD.

AIAC International Pharma, LLC

Hangzhou MSD Pharmaceutical Co Ltd (Primary and Secondary Packager)

Active Ingredients

FINASTERIDE

1 mg

Finasteride

Documents

Package Inserts

Propecia Tablet 1mg PI.pdf

Approved: September 5, 2022

Download

Patient Information Leaflets

Propecia Tablet 1mg PIL.pdf

Approved: September 5, 2022

Download

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PROPECIA TABLET 1 mg - HSA Approval | MedPath