MEZAVANT XL Gastro-resistant, prolonged release tablets Ref.[6971] Active ingredients: Mesalazine

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Shire Pharmaceutical Contracts Ltd, 1 Kingdom Street, London, W2 6BD, United Kingdom

Product name and form

Mezavant XL 1200mg, gastro-resistant, prolonged release tablets.

Pharmaceutical Form
Gastro-resistant, prolonged release tablets. Red-brown, ellipsoidal, film-coated tablet, debossed on one side with S476.

Qualitative and quantitative composition

Each tablet contains 1200mg mesalazine.

For a full list of excipients, see section 6.1.

Active Ingredient	Description
Mesalazine	Mesalazine is an aminosalicylate. The mechanism of action of mesalazine is not fully understood, but appears to have a topical anti-inflammatory effect on the colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase and lipoxygenase pathways, is increased in patients with chronic inflammatory bowel disease, and it is possible that mesalazine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

List of Excipients
Tablet core: Carmellose sodium Carnauba wax Stearic acid Silica, colloidal hydrated Sodium starch glycolate (Type A) Talc Magnesium stearate Film-coating: Talc Methacrylic acid – Methyl methacrylate copolymer (1:1) Methacrylic acid – Methyl methacrylate copolymer (1:2) Triethylcitrate Titanium dioxide (E171) Red ferric oxide (E172) Macrogol 6000

Pack sizes and marketing

Tablets are packed in polyamide/aluminium/PVC foil blister packs with aluminium push-through foil.

Packs contain 60 or 120 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Shire Pharmaceutical Contracts Ltd, 1 Kingdom Street, London, W2 6BD, United Kingdom

Marketing authorization dates and numbers

PL 08081/0040

Date of first authorisation: 23^rd February 2007
Date of last renewal: 13^th December 2011

Drugs

Drug	Countries
MEZAVANT	Austria, Australia, Canada, Cyprus, Germany, Estonia, Spain, Hong Kong, Ireland, Malta, Netherlands, Poland, Singapore, United Kingdom, South Africa

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