OXERVATE Eye drops, solution Ref.[7635] Active ingredients: Cenegermin

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

Product name and form

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.

Qualitative and quantitative composition

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
Mannitol
Disodium hydrogen phosphate, anhydrous
Sodium dihydrogen phosphate, dihydrate
Hydroxypropylmethylcellulose
Polyethylene glycol 6000
L-Methionine
Water for injections
Hydrochloric acid (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)
Nitrogen

Pack sizes and marketing

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/17/1197/001

Date of first authorisation: 06 July 2017

Drugs

Drug Countries
OXERVATE Austria, Estonia, Ireland, Israel, Lithuania, Poland, United States

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