Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Dompé farmaceutici S.p.A., Via Santa Lucia, 6, 20122 Milano Italy, Tel. +39 02 583831, Fax +39 02 58383215, E-mail: info@dompe.com
OXERVATE 20 micrograms/ml eye drops, solution.
| Pharmaceutical Form |
|---|
|
Eye drops, solution (eye drops). Clear, colourless solution. pH 7.0-7.4 and osmolarity 280-320 mOsm/kg. |
One ml of solution contains 20 micrograms of cenegermin*.
* Recombinant form of human nerve growth factor produced in Escherichia Coli.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Cenegermin |
Cenegermin, a recombinant form of human nerve growth factor. Nerve growth factor is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (i.e. TrkA) and low-affinity (i.e. p75NTR) nerve growth factor receptors. The treatment with cenegermin, administered as eye drops, is intended to allow restoration of corneal integrity. |
| List of Excipients |
|---|
|
Trehalose dihydrate |
1 ml OXERVATE solution in sterile, preservative-free multi-dose Type I glass vials, closed with a rubber stopper and an aluminium overseal with a polypropylene flip-off cap, presented in cardboard cartons.
Pack size: 7 multi-dose vials per carton
The patient will receive a weekly carton containing 7 vials of OXERVATE.
This medicinal product should only be used with specific vial adapters and disposable devices (pipettes) that will be provided separately from the weekly OXERVATE carton. 7 vial adapters (i.e. 1 per day), 42 pipettes (i.e. 6 per day) and 42 disinfectant wipes (i.e. 6 per day) sufficient to administer the medicinal product for one week will be provided separately, together with a dose recording card. Extra adapter (1), pipettes (3) and wipes (3) will also be provided as spares.
Domp̩ farmaceutici S.p.A., Via Santa Lucia, 6, 20122 Milano РItaly, Tel. +39 02 583831, Fax +39 02 58383215, E-mail: info@dompe.com
EU/1/17/1197/001
Date of first authorisation: 06 July 2017
| Drug | Countries | |
|---|---|---|
| OXERVATE | Austria, Estonia, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, United States |
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