Montelukast

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Montelukast sodium 5.19 mg equivalent to 5 mg montelukast free acid
Available from:
REX Medical Ltd
INN (International Name):
Montelukast sodium 5.19 mg (equivalent to 5 mg montelukast free acid)
Dosage:
5 mg
Pharmaceutical form:
Chewable tablet
Composition:
Active: Montelukast sodium 5.19 mg equivalent to 5 mg montelukast free acid Excipient: Aspartame Cherry flavour 11035-31 Croscarmellose sodium Hyprolose Iron oxide red Magnesium stearate Mannitol Microcrystalline cellulose
Prescription type:
Prescription
Manufactured by:
Formosa Laboratories Inc.
Therapeutic indications:
Montelukast is indicated in adult and paediatric patients 2 years of age and older for the prophylaxis and chronic treatment of asthma, including the prevention of day- and night-time symptoms and the prevention of exercise-induced bronchospasm. Montelukast is indicated in adults and paediatric patients 2 years of age and older for the relief of daytime and night time symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.
Product summary:
Package - Contents - Shelf Life: Blister pack, Alu foil & 3-ply alu-alu blister - 28 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture
Authorization number:
TT50-9996a
Authorization date:
2016-06-24

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