Gencebok
caffeine citrate
Table of contents
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.
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List item
Gencebok : EPAR - Medicine overview (PDF/145.17 KB)
First published: 27/08/2020
EMA/353540/2020 -
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List item
Gencebok : EPAR - Risk-management-plan summary (PDF/171.62 KB)
First published: 27/08/2020
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 |
Product information
22/02/2022 Gencebok - EMEA/H/C/005435 - N/0008
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.