Arixtra
fondaparinux sodium
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Arixtra. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Arixtra.
Authorisation details
Product details | |
---|---|
Name |
Arixtra
|
Agency product number |
EMEA/H/C/000403
|
Active substance |
fondaparinux sodium
|
International non-proprietary name (INN) or common name |
fondaparinux sodium
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
B01AX05
|
Publication details | |
---|---|
Marketing-authorisation holder |
Mylan IRE Healthcare Limited
|
Revision |
34
|
Date of issue of marketing authorisation valid throughout the European Union |
20/03/2002
|
Contact address |
Unit 35/36 Grange Parade |
Product information
28/10/2022 Arixtra - EMEA/H/C/000403 - N/0086
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Antithrombotic agents
Therapeutic indication
1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injection
Prevention of venous thromboembolic events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery.
Prevention of VTE in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery.
Prevention of VTE in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and / or acute respiratory disorders, and / or acute infectious or inflammatory disease.
Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.
2.5-mg/0.5-ml solution for injection
Treatment of unstable angina or non-ST-segment-elevation myocardial infarction (UA/NSTEMI) in adult patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated.
infarction (STEMI) in adult patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy.
5-mg/0.4-ml, 7.5-mg/0.6-ml and 10-mg/0.8-ml solution for injection
Treatment of adults with acute deep-vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.