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OPTILAST Eye drops (2018)

Product Name and Form

Optilast.

0.5 mg/ml, Eye Drops, solution.

Pharmaceutical form

Eye drops, solution.

Clear, colourless solution.

Qualitative and Quantitative Composition

Azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015 mg azelastine hydrochloride.

Excipient with known effect: 1 ml contains 0.125 mg benzalkonium chloride.

For the full list of excipients see section 6.1.

List of excipients

Benzalkonium chloride (preservative)
Disodium edetate
Hypromellose
Sorbitol
(crystallising) Sodium hydroxide
Water for injections

Pack sizes and Marketing

10 ml opaque HDPE bottle and LDPE dropper with white HDPE screw cap. One bottle contains either 6 ml, 8 ml or 10 ml solution. Not all volume fill sizes are marketed in all Member States.

Marketing authorization holder
Authorization dates

Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

1st August 2009

Marketing authorization number:

PL 46302/0136