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IKERVIS Eye drops, emulsion (2017)

Active ingredients: Ciclosporin

Product Name and Form

IKERVIS 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.

Chemical substance
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

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

One pouch contains five single-dose containers.

Pack sizes: 30 and 90 single-dose containers.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

SANTEN Oy, Niittyhaankatu 20, 33720, Tampere, Finland

Date of first authorisation: 19 March 2015

Marketing authorization number:

EU/1/15/990/001

EU/1/15/990/002