ALLERCROM Eye drops, solution Ref.[28082] Active ingredients: Cromoglicic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: FDC International Ltd, Unit 6 Fulcrum 1, Solent Way, Solent Business Park, Whiteley, Fareham Hampshire PO15 7FE, United Kingdom

Product name and form

Allercrom 2% w/v Eye Drops.

Pharmaceutical Form

Eye drops, solution.

A clear, colourless solution. Free from visible particulate matter.

Qualitative and quantitative composition

Active substance: Sodium cromoglicate (equivalent to 20.0 mg/ml anhydrous Sodium Cromoglicate).

[Sodium Cromoglicate 2.0% w/v]

Excipient(s) with known effect: Benzalkonium chloride 0.10 mg/ml

For the full list of excipients, see section 6.1

Active Ingredient Description
Cromoglicic acid

Sodium cromoglicate (Cromoglicic acid) inhibits the activation of many of the cell types involved in the development and progression of asthma. Thus, sodium cromoglicate inhibits the release of inflammatory mediators including cytokines from mast cells and reduces the chemotactic activity of eosinophils and neutrophils.

List of Excipients

Benzalkonium chloride
Disodium edetate
Sodium Chloride
Polysorbate 80
Water for Injection

Pack sizes and marketing

Low Density Polyethylene BFS bottles with a polystyrene spiked cap which contains 5 mL and 10 mL of Sodium Cromoglicate 2 % w/v Eye Drops solution.

Not all pack sizes may be marketed.

Marketing authorization holder

FDC International Ltd, Unit 6 Fulcrum 1, Solent Way, Solent Business Park, Whiteley, Fareham Hampshire PO15 7FE, United Kingdom

Marketing authorization dates and numbers

PL 15872/0008

16 May 2007 / 05 March 2012

Drugs

Drug Countries
ALLERCROM Hong Kong, United Kingdom

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