FROBEN Coated tablet Ref.[8115] Active ingredients: Flurbiprofen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Froben Tablets 50 mg.

Flurbiprofen 50 mg coated tablets.

Pharmaceutical Form

The tablets are 7.6 mm in diameter, sugar-coated and white in colour.

Qualitative and quantitative composition

Froben Tablets 50mg contain 50 mg flurbiprofen EP.

Flurbiprofen 50 mg coated tablets contain 50 mg flurbiprofen EP.

Excipients with known effect:

Sucrose
Glucose
Lactose

Active Ingredient Description
Flurbiprofen

Flurbiprofen is a propionic acid derivative NSAID which acts through inhibition of prostaglandin synthesis. In humans flurbiprofen has potent analgesic, antipyretic and anti-inflammatory properties.

List of Excipients

Maize starch
Lactose
Povidone
Magnesium stearate
Stearic acid
Sandarac gum
Sucrose
Talc
Liquid glucose
Titanium dioxide
Colloidal silica
Carnauba wax

Pack sizes and marketing

A blister pack consisting of a PVC blister heat sealed to hard temper aluminium foil packed in a cardboard carton. Each blister contains 10 tablets.

Pack sizes: 10, 20, 30, 100 and 500 tablets. Also a sample pack of 5 tablets in a blister.

A bulk pack of a low density polyethylene bag in a rectangular white plastic tub having a snap-on lid.

Pack sizes: Approx. 25,000 or 50,000 tablets.

Marketing authorization holder

Mylan Products Ltd., 20 Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

Froben Tablets 50 mg:

Flurbiprofen 50 mg coated tablets:

PL 46302/0013

21/07/1995

Drugs

Drug Countries
FROBEN Estonia, Japan, Lithuania, South Africa

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