VERKAZIA Eye drops, emulsion Ref.[27520] Active ingredients: Ciclosporin

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland

Product name and form

Verkazia 1 mg/mL eye drops, emulsion.

Pharmaceutical Form

Eye drops, emulsion.

Milky white emulsion.

Qualitative and quantitative composition

One mL of emulsion contains 1 mg of ciclosporin.

Excipient with known effect: One mL of emulsion contains 0.05 mg cetalkonium chloride (see section 4.4).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ciclosporin

Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide immunomodulator with immunosuppressant properties. It has been shown to prolong survival of allogeneic transplants in animals and significantly improved graft survival in all types of solid organ transplantation in man. Ciclosporin has also been shown to have an anti-inflammatory effect.

List of Excipients

Medium-chain triglycerides
Cetalkonium chloride
Glycerol
Tyloxapol
Poloxamer 188
Sodium hydroxide (to adjust pH)
Water for injections

Pack sizes and marketing

0.3 mL single-dose, low-density polyethylene (LDPE) containers in a sealed laminate aluminium pouch.

One pouch contains 5 single-dose containers.

Pack sizes of 30, 60, 90 or 120 single-dose containers.

Not all pack sizes may be marketed.

Marketing authorization holder

Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland

Marketing authorization dates and numbers

EU/1/17/1219/001
EU/1/17/1219/002
EU/1/17/1219/003
EU/1/17/1219/004

Drugs

Drug Countries
VERKAZIA Austria, Canada, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom

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