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EMA Product

Gencebok

Product approved by European Medicines Agency (EU)

Basic Information

Gencebok

Regulatory Information

EMEA/H/C/005435

Authorised

August 19, 2020

June 25, 2020

8

March 12, 2025

Company Information

13127 vitrolles - france

Swen Parc de Vitrolles Chemin de la Bastide Blanche

GENNISIUM PHARMA

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Treatment of primary apnoea of premature newborns.

Overview Summary

Gencebok is a stimulant medicine used for treating apnoea of prematurity, a condition in which babies born prematurely stop breathing for longer than 20 seconds. Gencebok contains the active substance caffeine citrate. Gencebok is a ‘hybrid’ medicine. This means that it is similar to a ‘reference medicine’ containing the same active substance, but at a different strength. The reference medicine for Gencebok is Peyona.

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