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HSA Approval

FINAPECIA 1 FILM COATED TABLET 1 MG

SIN16530P

FINAPECIA 1 FILM COATED TABLET 1 MG

FINAPECIA 1 FILM COATED TABLET 1 MG

June 29, 2022

ACCORD HEALTHCARE PRIVATE LIMITED

ACCORD HEALTHCARE PRIVATE LIMITED

Regulatory Information

ACCORD HEALTHCARE PRIVATE LIMITED

ACCORD HEALTHCARE PRIVATE LIMITED

Therapeutic

Prescription Only

Formulation Information

TABLET, FILM COATED

**DOSAGE AND ADMINISTRATION** The recommended dosage is one 1-mg tablet daily. FINAPECIA 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

**INDICATIONS** FINAPECIA is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss. FINAPECIA 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.

**CONTRAINDICATIONS** Finasteride 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 Finasteride is not indicated for use in women or children.

D11AX10

finasteride

Manufacturer Information

ACCORD HEALTHCARE PRIVATE LIMITED

Intas Pharmaceuticals Limited

Active Ingredients

Finasteride

1 mg

Finasteride

Documents

Package Inserts

Finapecia 1 Tablet PI.pdf

Approved: June 29, 2022

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FINAPECIA 1 FILM COATED TABLET 1 MG - HSA Approval | MedPath