Elocta

RSS

efmoroctocog alfa

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

Overview

Elocta is a medicine used to treat and prevent bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). It contains the active substance efmoroctocog alfa.

This EPAR was last updated on 12/12/2018

Authorisation details

Product details
Name
Elocta
Agency product number
EMEA/H/C/003964
Active substance
efmoroctocog alfa
International non-proprietary name (INN) or common name
efmoroctocog alfa
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
Marketing-authorisation holder
Swedish Orphan Biovitrum AB (publ)
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
18/11/2015
Contact address
SE-112 76
112 76 Stockholm
Sweden

Product information

30/01/2018 Elocta - EMEA/H/C/003964 - N/0020

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTIHEMORRHAGICS
 

Therapeutic indication

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

Elocta can be used for all age groups.

Assessment history

How useful was this page?

Add your rating