Source: European Medicines Agency (EU) | Revision Year: 2017 | Publisher: SANTEN Oy, Niittyhaankatu 20, 33720, Tampere, Finland
IKERVIS 1 mg/mL eye drops, emulsion.
Eye drops, emulsion.
Milky white emulsion.
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.
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.
Medium-chain triglycerides
Cetalkonium chloride
Glycerol
Tyloxapol
Poloxamer 188
Sodium hydroxide (to adjust pH)
Water for injections
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.
SANTEN Oy, Niittyhaankatu 20, 33720, Tampere, Finland
EU/1/15/990/001
EU/1/15/990/002
Date of first authorisation: 19 March 2015
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