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IOPIDINE Eye drops, solution (2020)

Active ingredients: Apraclonidine

Product Name and Form

IOPIDINE 5mg/ml Eye Drops, Solution.

Pharmaceutical form

Eye drops, solution.

A colourless to pale yellow solution.

Qualitative and Quantitative Composition

1 ml of solution contains Apraclonidine 5 mg (as hydrochloride).

Excipients with known effect: 1 ml of solution contains 0.1 mg benzalkonium chloride.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Apraclonidine

Apraclonidine is an α2-adrenergic receptor agonist and a weak α1-adrenergic receptor agonist. It is used for the prevention and treatment of postsurgical intraocular pressure elevation.

List of excipients

Benzalkonium chloride
Sodium acetate (trihydrate)
Sodium chloride
Hydrochloric acid and/or Sodium hydroxide (for pH adjustment)
Purified water

Pack sizes and Marketing

5 ml and/or 10 ml white LDPE DROP-TAINER dispensers with a natural LDPE dispensing plug and white polypropylene closure.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom

29 December 1994 / 02 December 2009

Marketing authorization number:

PL 00101/0996