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Emadine 0.05% w/v, Eye drops, Solution (2011)

Active ingredients: Emadine

Product Name and Form

EMADINE 0.5 mg/ml, Eye Drops, solution.

Pharmaceutical form

Eye drops, (solution).

Clear, colourless solution.

Qualitative and Quantitative Composition

1 ml of solution contains emedastine 0.5 mg (as difumarate)

Excipients: Benzalkonium chloride 0.1 mg/ml

For a full list of excipients, see section 6.1

Chemical substance
Description
Emadine

Emedastine is a potent selective and topically effective histamine H1 antagonist. In vivo topical ocular administration of emedastine produces a concentration-dependent inhibition of histamine-stimulated conjunctival vascular permeability.

List of excipients

Benzalkonium chloride 0.1 mg/ml
Trometamol
Sodium chloride
Hypromellose
Hydrochloric acid/sodium hydroxide (to adjust pH)
Purified water

Pack sizes and Marketing

EMADINE is supplied in 5 ml and 10 ml opaque plastic DROP-TAINER bottles.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Alcon Laboratories (UK) Ltd
Pentagon Park
Boundary Way
Hemel Hempstead
Herts HP2 7UD
United Kingdom

Date of first authorisation: 27th January 1999

Date of last renewal: 29th January 2004

Marketing authorization number:

EU/1/98/095/001-2