GENCEBOK Solution for infusion Ref.[49869] Active ingredients: Caffeine

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Gennisium Pharma, Swen Parc de Vitrolles, Chemin de la Bastide Blanche, 13127 Vitrolles France

Product name and form

Gencebok 10 mg/ml solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear, colourless, aqueous solution, with a pH of 4.8 and an osmolality of 65 to 95 mOsm/kg.

Qualitative and quantitative composition

Each ml contains 10 mg caffeine citrate (equivalent to 5 mg caffeine).

Each 1 ml ampoule contains 10 mg caffeine citrate (equivalent to 5 mg caffeine).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Caffeine

Caffeine is structurally related to the methylxanthines theophylline and theobromine. Caffeine’s main action is as a CNS stimulant.

List of Excipients

Citric acid monohydrate
Sodium citrate
Water for injections

Pack sizes and marketing

Type I clear glass 1 ml ampoule coded by 2 blue rings.

Pack size of 50 ampoules.

Marketing authorization holder

Gennisium Pharma, Swen Parc de Vitrolles, Chemin de la Bastide Blanche, 13127 Vitrolles – France

Marketing authorization dates and numbers

EU/1/20/1465/001

Date of first authorisation: 19 August 2020

Drugs

Drug Countries
GENCEBOK Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland

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