OPTICROM Allergy Eye drops, solution Ref.[27787] Active ingredients: Cromoglicic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aspire Pharma Limited, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom

Product name and form

Opticrom Allergy 2%w/v Eye Drops, Solution.

Pharmaceutical Form

Eye Drops, Solution (eye drops).

Clear colourless to pale yellow solution.

Qualitative and quantitative composition

Each ml of eye drops contains.

Active substance: 20 mg sodium cromoglicate (2.0% w/v), (one drop contains 0.7mg sodium cromoglicate).

Excipient with known effect: 0.1mg benzalkonium chloride

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

Disodium edetate
Benzalkonium chloride
Water for injections

Pack sizes and marketing

Low density polyethylene (LDPE) bottle with a low density polyethylene/ high density polyethylene cap with a tamper proof cap containing either 5ml or 10ml of solution.

Pack sizes: 1x5ml and 1x10ml

Not all pack sizes may be marketed.

Marketing authorization holder

Aspire Pharma Limited, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom

Marketing authorization dates and numbers

PL 35533/0033

21/08/2018

Drugs

Drug Countries
OPTICROM Canada, Ireland, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.