SAFLUTAN Eye drops, solution Ref.[8556] Active ingredients: Tafluprost

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Santen Oy, Niittyhaankatu 20, 33720, Tampere, Finland

Product name and form

Saflutan 15 micrograms/ml eye drops, solution.

Pharmaceutical Form

Eye drops, solution (eye drops).

A clear, colourless solution, practically free from visible particles with a pH between 5.5 and 6.7, and an osmolality of 260-300 mOsmol/kg.

Qualitative and quantitative composition

One ml of solution contains 15 micrograms of tafluprost.

One drop contains about 0.45 micrograms of tafluprost.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tafluprost

Tafluprost is a fluorinated analogue of prostaglandin F2α. Tafluprost acid, the biologically active metabolite of tafluprost, is a highly potent and selective agonist of the human prostanoid FP receptor.

List of Excipients

Glycerol
Sodium dihydrogen phosphate dihydrate
Disodium edetate
Polysorbate 80
Hydrochloric acid and/or sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

Transparent low-density polyethylene (LDPE) bottles with white Aptar OSD (polyethylene, polypropylene, cyclic olefin copolymer) with blue polyethylene cap packed in a PET coated aluminium/polyethylene foil pouch. Each bottle has a fill volume of 3 ml.

The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml each packed in pouch.

Not all pack sizes may be marketed.

Marketing authorization holder

Santen Oy, Niittyhaankatu 20, 33720, Tampere, Finland

Marketing authorization dates and numbers

PL 16058/0026

11/02/2019

Drugs

Drug Countries
SAFLUTAN Austria, Australia, Brazil, Cyprus, Spain, Croatia, Ireland, Israel, Malta, Mexico, Netherlands, Romania, Tunisia, United Kingdom, South Africa

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