TRAVATAN Eye drops, solution Ref.[8289] Active ingredients: Travoprost

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

TRAVATAN 40 micrograms/mL eye drops, solution.

Pharmaceutical Form

Eye drops, solution. (eye drops)

Clear, colourless solution.

Qualitative and quantitative composition

Each mL of solution contains 40 micrograms of travoprost.

Excipient(s) with known effect: Each mL of solution contains polyquaternium-1 (POLYQUAD) 10 microgram, propylene glycol 7.5 mg, polyoxyethylene hydrogenated castor oil 40 (HCO-40) 2 mg (see section 4.4.).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Travoprost

Travoprost, a prostaglandin F analogue, is a highly selective full agonist which has a high affinity for the prostaglandin FP receptor, and reduces the intraocular pressure by increasing the outflow of aqueous humour via trabecular meshwork and uveoscleral pathways.

List of Excipients

Polyquaternium-1
Polyoxyethylene hydrogenated castor oil 40 (HCO-40)
Boric acid (E284)
Mannitol (E421)
Sodium chloride
Propylene glycol (E1520)
Sodium hydroxide and/or hydrochloric acid (for pH-adjustment)
Purified water

Pack sizes and marketing

4 mL oval Polypropylene (PP) or Low Density Polyethylene (LDPE) bottle and PP or LDPE dispensing plug with a PP screw cap, presented in an overwrap. Each 4 mL bottle will contain 2.5 mL of solution.

Cartons containing 1 or 3 bottles.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/01/199/001-004

Date of first authorisation: 27 November 2001

Date of latest renewal: 06 October 2006

Drugs

Drug Countries
TRAVATAN Austria, Australia, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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