CALCORT Tablet Ref.[9566] Active ingredients: Deflazacort

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: 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

Product name and form

Calcort 6mg Tablets.

Pharmaceutical Form

Tablet.

Round, white, uncoated tablets, marked with a cross on one face and a 6 on the other face.

Qualitative and quantitative composition

Active substance: Deflazacort 6mg.

Excipient(s) with known effect: Lactose monohydrate 153mg.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Deflazacort

Deflazacort is a glucocorticoid. Its anti-inflammatory and immunosuppressive effects are used in treating a variety of diseases and are comparable to other anti-inflammatory steroids.

List of Excipients

Microcrystalline cellulose
Lactose monohydrate
Maize starch
Magnesium stearate

Pack sizes and marketing

Deflazacort is packed in blister packs of polyvinylchloride and aluminium foil presented in cardboard cartons. Each pack contains 60 tablets.

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 04425/0629

Date of first authorisation: 28 April 1994
Date of latest renewal: 30 March 2005

Drugs

Drug Countries
CALCORT Brazil, Germany, Estonia, Mexico, United Kingdom

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