Esperoct

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turoctocog alfa pegol

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

Overview

Esperoct is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by the lack of a clotting protein known as factor VIII. Esperoct can be used in adults and children from 12 years of age.

Esperoct contains the active substance turoctocog alfa pegol.

This EPAR was last updated on 22/12/2022

Authorisation details

Product details
Name
Esperoct
Agency product number
EMEA/H/C/004883
Active substance
Turoctocog alfa pegol
International non-proprietary name (INN) or common name
turoctocog 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
Novo Nordisk A/S
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
20/06/2019
Contact address

Novo Allé
DK-2880 Bagsvaerd
Denmark

Product information

30/11/2022 Esperoct - EMEA/H/C/004883 - IB/0017/G

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

Antihemorrhagics

Therapeutic indication

Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).

Assessment history

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