MELOREX Tablet Ref.[50648] Active ingredients: Meloxicam

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2022  Publisher: REX Medical Ltd, Unit 18/273 Neilson Street, Onehunga, Auckland 1061, PO Box 18-119, Glen Innes 1743, AUCKLAND Ph (09) 574 6060 Fax (09) 574 6070

Product name and form

Melorex.

Pharmaceutical Form

Melorex 7.5 mg tablets are pale yellow coloured, circular flat beveled uncoated tablets.

Melorex 15 mg tablets are pale yellow coloured, circular flat beveled uncoated tablets with central breakline on one side and plain on the other.

Qualitative and quantitative composition

Meloxicam tablets 7.5 mg, 15 mg.

Excipient(s) with known effect:

Each 7.5 mg tablet contains 43 mg of lactose monohydrate.

Each 15 mg tablet contains 86 mg of lactose monohydrate.

For full list of excipients, see section 6.1.

Active Ingredient Description
Meloxicam

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam family, with anti-inflammatory, analgesic and antipyretic properties. The anti-inflammatory activity of meloxicam has been proven in classical models of inflammation. As with other NSAID, its precise mechanism of action remains unknown. However, there is at least one common mode of action shared by all NSAID (including meloxicam): inhibition of the biosynthesis of prostaglandins, known inflammation mediators.

List of Excipients

Colloidal anhydrous silica
Pregelatinised starch 1500
Lactose monohydrate
Magnesium stearate
Maize starch
Microcrystalline cellulose
Sodium citrate dihydrate

Pack sizes and marketing

Al/PVC/PVdC blister packs:

7.5mg = 30 tablets

15mg = 30 tablets

Marketing authorization holder

REX Medical Ltd, Unit 18/273 Neilson Street, Onehunga, Auckland 1061, PO Box 18-119, Glen Innes 1743, AUCKLAND
Ph (09) 574 6060
Fax (09) 574 6070

Marketing authorization dates and numbers

Date of first approval: 15 November 2007

Drugs

Drug Countries
MELOREX Ecuador, New Zealand

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