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Optilast Eye drops (2012)

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.

For 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

Meda Pharmaceuticals Ltd
249 West George Street
Glasgow
G2 4RB

Trading as:

Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU
UK

1st August 2009

Marketing authorization number:

PL 15142/0036