Jivi

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damoctocog alfa pegol

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

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.

This EPAR was last updated on 11/11/2021

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 monitoringAdditional 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
Marketing-authorisation holder
Bayer AG
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
22/11/2018
Contact address

Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Product information

20/10/2021 Jivi - EMEA/H/C/004054 - N/0020

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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

Antihemorrhagics

Therapeutic indication

Treatment and prophylaxis of bleeding in previously treated patients ≥ 12 years of age with haemophilia A (congenital factor VIII deficiency).

Assessment history

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