NALCROM Capsule Ref.[7204] Active ingredients: Cromoglicic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Product name and form

Nalcrom 100mg Capsules.

Pharmaceutical Form

Capsule.

Hard gelatin capsule with a clear cap and body, marked ‘SODIUM CROMOGLICATE 100 mg’ in black and containing a white powder.

Qualitative and quantitative composition

The active component per capsule is: Sodium Cromoglicate 100.0mg.

For a 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

Purified water
No 2 hard gelatin capsules

Black ink containing:

Water
Ethyl alcohol
Iso-propyl alcohol
Propylene alcohol
N-butyl alcohol
Shellac
Ammonium hydroxide
Potassium hydroxide
Iron oxide black (E172)

Pack sizes and marketing

An aluminium can with aluminium screw cap containing 100 capsules or an HDPE bottle with screw cap containing 100 capsules.

Marketing authorization holder

Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

or trading as:

Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Marketing authorization dates and numbers

PL 04425/0370

1st May 2005

Drugs

Drug Countries
NALCROM Canada, Estonia, Netherlands, New Zealand, United Kingdom

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