CATAFAST Powder for oral solution Ref.[51132] Active ingredients: Diclofenac

Source: Medicines Authority (MT)  Revision Year: 2019  Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland

Product name and form

Catafast 50 mg powder for oral solution.

Pharmaceutical Form

Powder for oral solution.

Homogenous, white to light yellow powder.

Qualitative and quantitative composition

The active ingredient is diclofenac potassium. One Catafast sachet contains 50 mg of diclofenac potassium.

Active Ingredient Description
Diclofenac

Diclofenac is a non-steroidal anti-inflammatory drug. The mechanism of action of diclofenac in AK may be related to the inhibition of the cycloxygenase pathway leading to reduced prostaglandin E2 (PGE2) synthesis. In addition, immunohistochemistry (IHC) from skin biopsies ac revealed that the clinical effects of diclofenac in AK are primarily due to anti-inflammatory, anti-angiogenic and possibly anti-proliferative effects and apoptosis-inducing mechanisms.

List of Excipients

Potassium hydrogen carbonate
Mannitol SD 200
Mannitol 35
Aspartame
Saccharin sodium
Glyceryl dibehenate
Mint flavour
Anise flavour

Pack sizes and marketing

Sachet hermetically sealed in four directions made of coupled paper/aluminium/polyethylene in an outer carton box.

Pack sizes of 3,9,21 and 30 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland

Marketing authorization dates and numbers

Catafast 50mg powder for oral solution: MA1249/00203

Date of first authorisation: 3rd August 2006
Date of latest renewal: 29th April 2013

Drugs

Drug Countries
CATAFAST Malta, South Africa

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