ARTELAC Eye drops, solution Ref.[27653] Active ingredients: Hypromellose

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Bausch + Lomb Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24 PPT3, Ireland

Product name and form

Artelac 3.2 mg/ml Eye Drops, Solution.

Pharmaceutical Form

Eye drops, solution.

Sterile solution for eye drops.

Qualitative and quantitative composition

Each ml of solution contains 3.2 mg hypromellose equivalent to hypromellose 0.32% w/v.

Excipients with known effect: Disodium phosphate dodecahydrate and Sodium dihydrogen phosphate dihydrate (0.051 mg phosphates in each drop which is equivalent to 1.84 mg/ml).

For full list of excipients, see section 6.1.

Active Ingredient Description
Hypromellose
List of Excipients

Cetrimide
Disodium phosphate dodecahydra
Sodium dihydrogen phosphate dihydrate
Disodium edetate
Sorbitol (E420)
Water for injections

Pack sizes and marketing

10 ml round transparent white bottle (LDPE) with white dropper plug (LDPE) and white cap (HDPE).

Marketing authorization holder

Bausch + Lomb Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24 PPT3, Ireland

Marketing authorization dates and numbers

PA23259/004/001

Date of first authorisation: 09 July 1996
Date of last renewal: 09 July 2006

Drugs

Drug Countries
ARTELAC Germany, Estonia, Finland, France, Ireland, Lithuania, Netherlands, Poland, Tunisia, United Kingdom

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