FLAMARYX Tablet Ref.[51178] Active ingredients: Meloxicam

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2012  Publisher: Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa

Product name and form

FLAMARYX 7,5 mg (tablet).

FLAMARYX 15 mg (tablet).

Pharmaceutical Form

Tablet.

FLAMARYX 7,5 mg: Light yellow, round, uncoated tablets with score line between ‘F’ and ‘1’ debossed on one side and plain on the other side.

FLAMARYX 15 mg: Light yellow, round, uncoated tablets with score line between ‘F’ and ‘2’ debossed on one side and plain on the other side.

Qualitative and quantitative composition

FLAMARYX 7,5 mg: Each uncoated tablet contains 7,5 mg meloxicam.

FLAMARYX 15 mg: Each uncoated tablet contains 15 mg meloxicam.

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

Pack sizes and marketing

FLAMARYX 7,5 mg:

Tablets are packed in 250 micron white opaque PVC coated with 60 gsm PVdC and printed aluminium foil with 7 gsm heat seal lacquer. 3 blisters containing 10 tablets each are packed into a printed cardboard carton.

Pack size: 30’s (3 × 10’s).

FLAMARYX 15 mg:

Tablets are packed in 250 micron white opaque PVC coated with 60 gsm PVdC and printed aluminium foil with 7 gsm heat seal lacquer. 3 blisters containing 10 tablets each are packed into a printed cardboard carton.

Pack size: 30’s (3 × 10’s).

Marketing authorization holder

Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa

Marketing authorization dates and numbers

SOUTH AFRICA:

FLAMARYX 7.5 mg: 42/3.1/0469
FLAMARYX 15 mg: 42/3.1/0470

NAMIBIA:

FLAMARYX 7,5 mg: 10/30.1/0078
FLAMARYX 15 mg: 10/30.1/0079

Date of registration: 23 July 2010

Drugs

Drug Countries
FLAMARYX South Africa

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