Esperoct
turoctocog alfa pegol
Table of contents
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.
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Esperoct : EPAR - Medicine overview (PDF/103.54 KB)
First published: 28/06/2019 -
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Esperoct : EPAR - Risk-management-plan summary (PDF/88.85 KB)
First published: 28/06/2019
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 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 |
Novo Nordisk A/S
|
Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
20/06/2019
|
Contact address |
Product information
25/08/2020 Esperoct - EMEA/H/C/004883 - IB/0004
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
Antihemorrhagics
Therapeutic indication
Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).