Gencebok

RSS

caffeine citrate

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 22/02/2022

Authorisation details

Product details
Name
Gencebok
Agency product number
EMEA/H/C/005435
Active substance
Caffeine citrate
International non-proprietary name (INN) or common name
caffeine citrate
Therapeutic area (MeSH)
Apnea
Anatomical therapeutic chemical (ATC) code
N06BC01
Publication details
Marketing-authorisation holder
Gennisium Pharma
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
19/08/2020
Contact address

Swen Parc de Vitrolles
Chemin de la Bastide Blanche
13127 Vitrolles - France

Product information

22/02/2022 Gencebok - EMEA/H/C/005435 - N/0008

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Psychoanaleptics

Therapeutic indication

Treatment of primary apnoea of premature newborns.

Assessment history

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