ORUVAIL Controlled release capsule

Active ingredients: Ketoprofen

Product name and form

Oruvail 100 mg Prolonged-Release Capsules, Hard.

Pharmaceutical Form

Controlled release capsules.

Qualitative and quantitative composition

Ketoprofen 100 mg.

Active Ingredient
Description

Ketoprofen is a non-steroidal anti-inflammatory drug. It has anti-inflammatory and analgesic actions.

List of Excipients

Pellets:

Sugar spheres
Colloidal anhydrous silica
Shellac
Ethylcellulose
Talc

Capsule shell – body:

Gelatin
Erythrosine (E127)

Capsule shell – cap:

Gelatin
Titanium dioxide (E171)
Erythrosine (E127)
Patent blue V (E131)

Pack sizes and marketing

Securitainer or HDPE bottle containing 100 capsules.

UPVC/Aluminium foil blister or UPVC coated with PVDC aluminium foil blister containing either 8, 28, 30 or 56 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0597

04 September 2006

Drugs

Drug
Countries
Australia, Ireland, New Zealand, United Kingdom