Jivi
damoctocog alfa pegol
Table of contents
Overview
Jivi is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by lack of a clotting protein called factor VIII. Jivi can be used in adults and children from 12 years of age who have been treated previously.
Jivi contains the active substance damoctocog alfa pegol.
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List item
Jivi : EPAR - Medicine overview (PDF/82.92 KB)
First published: 28/01/2019
EMA/661007/2018 -
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List item
Jivi : EPAR - Risk-management-plan summary (PDF/334.78 KB)
First published: 28/01/2019
Last updated: 06/09/2021
Authorisation details
Product details | |
---|---|
Name |
Jivi
|
Agency product number |
EMEA/H/C/004054
|
Active substance |
Damoctocog alfa pegol
|
International non-proprietary name (INN) or common name |
damoctocog alfa pegol
|
Therapeutic area (MeSH) |
Hemophilia A
|
Anatomical therapeutic chemical (ATC) code |
B02BD02
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Bayer AG
|
Revision |
5
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Date of issue of marketing authorisation valid throughout the European Union |
22/11/2018
|
Contact address |
Kaiser-Wilhelm-Allee 1 |
Product information
23/06/2023 Jivi - EMEA/H/C/004054 - R/0027
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
Antihemorrhagics
Therapeutic indication
Treatment and prophylaxis of bleeding in previously treated patients ≥ 12 years of age with haemophilia A (congenital factor VIII deficiency).