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HSA Approval

TELFAST TABLET 180 mg

SIN11699P

TELFAST TABLET 180 mg

TELFAST TABLET 180 mg

October 27, 2001

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantOPELLA HEALTHCARE SINGAPORE PTE. LTD.
Licence HolderOPELLA HEALTHCARE SINGAPORE PTE. LTD.

Product Classification

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

Formulation Information

TABLET, FILM COATED

**Dosage and method of administration** **Adults and children aged 12 years and older** The recommended dose is one tablet once daily. **Special risk groups** Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients.

ORAL

Medical Information

**Indications** **Telfast 180mg** is indicated for the relief of symptoms associated with Seasonal Allergic Rhinitis (SAR) and Chronic Idiopathic Urticaria (CIU) in adults and children 12 years of age and older.

**Contraindications** Fexofenadine is contraindicated in patients with known hypersensitivity to any of its ingredients.

R06AX26

fexofenadine

Manufacturer Information

OPELLA HEALTHCARE SINGAPORE PTE. LTD.

PT. Aventis Pharma

Active Ingredients

FEXOFENADINE HCl

180 mg

Fexofenadine

Documents

Package Inserts

Telfast Tablet 180mg PI.pdf

Approved: August 12, 2020

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TELFAST TABLET 180 mg - HSA Approval | MedPath