MedPath
HSA Approval

NORGESIC TABLET

SIN05552P

NORGESIC TABLET

NORGESIC TABLET

March 20, 1991

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantINOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
Licence HolderINOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Product Classification

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

Formulation Information

TABLET

**Dosage and Administration** 2 tablets three times daily

ORAL

Medical Information

**Indications** Tension headache, occipital headaches associated with spasm of skeletal muscles in the region of the head and neck. Acute and traumatic conditions of the limbs and trunk: sprains, strains, whiplash injuries, acute torticollis, prolapsed intervertebral disc.

**Contraindications** Orphenadrine shows some anticholinergic activity and should not be used in patients with glaucoma, prostatic hypertrophy or obstruction at the bladder neck, or myasthenia gravis.

M03BC51

orphenadrine, combinations

Manufacturer Information

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Adcock Ingram Limited

Active Ingredients

ORPHENADRINE CITRATE

35 mg

Orphenadrine

PARACETAMOL

450 mg

Acetaminophen

Documents

Package Inserts

Norgesic Tablet PI.pdf

Approved: December 6, 2018

Download

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

NORGESIC TABLET - HSA Approval | MedPath