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HSA Approval

URIPAX FILM COATED TABLET 200MG

SIN16400P

URIPAX FILM COATED TABLET 200MG

URIPAX FILM COATED TABLET 200MG

December 14, 2021

YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantYUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
Licence HolderYUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

Product Classification

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

Formulation Information

TABLET, FILM COATED

**Dosage and Administration:** Adults (including the elderly): The recommended adult dosage is 200mg three times a day for as long as required. Children: Not recommended for children under 12 years of age.

ORAL

Medical Information

**Indication(s):** Symptomatic relief of dysuria, urgency, vesical suprapubic pain, nocturia, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis and urethrotrigonitis. Relief of vesico-urethral spasm due to catheterization, cystoscopy or indwelling catheters, prior to cystoscopy or catheterisation, and sequelae of surgical intervention of the lower urinary tract.

**Contraindication(s):** Flavoxate is contraindicated in patients who have hypersensitivity to the active substance or to any of the excipients, gastrointestinal obstructive conditions or ileus, gastrointestinal haemorrhage, achalasia, urinary retention, glaucoma and myasthenia gravis.

G04BD02

flavoxate

Manufacturer Information

YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD

Y.S.P. Industries (M) Sdn. Bhd.

Active Ingredients

Flavoxate Hydrochloride

200mg

Flavoxate

Documents

Package Inserts

Uripax Film Coated Tablet PI.pdf

Approved: January 27, 2023

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URIPAX FILM COATED TABLET 200MG - HSA Approval | MedPath