Elocta
efmoroctocog alfa
Table of contents
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.
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List item
Elocta : EPAR - Medicine overview (PDF/73.56 KB)
First published: 10/12/2015
Last updated: 12/12/2018
EMA/660642/2015 -
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List item
Elocta : EPAR - Risk-management-plan summary (PDF/46.92 KB)
First published: 03/09/2020
This EPAR was last updated on 26/02/2021
Authorisation details
Product details | |
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Name |
Elocta
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Agency product number |
EMEA/H/C/003964
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Active substance |
efmoroctocog alfa
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International non-proprietary name (INN) or common name |
efmoroctocog alfa
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Therapeutic area (MeSH) |
Hemophilia A
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Anatomical therapeutic chemical (ATC) code |
B02BD02
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Publication details | |
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Marketing-authorisation holder |
Swedish Orphan Biovitrum AB (publ)
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Revision |
11
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Date of issue of marketing authorisation valid throughout the European Union |
18/11/2015
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Contact address |
Product information
11/01/2021 Elocta - EMEA/H/C/003964 - II/0039
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Pharmacotherapeutic group
Antihemorrhagics
Therapeutic indication
Therapeutic indication
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Elocta can be used for all age groups.