Inhixa
enoxaparin sodium
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Inhixa. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Inhixa.
For practical information about using Inhixa, patients should read the package leaflet or contact their doctor or pharmacist.
Authorisation details
Product details | |
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Name |
Inhixa
|
Agency product number |
EMEA/H/C/004264
|
Active substance |
enoxaparin sodium
|
International non-proprietary name (INN) or common name |
enoxaparin sodium
|
Therapeutic area (MeSH) |
Venous Thromboembolism
|
Anatomical therapeutic chemical (ATC) code |
B01AB05
|
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. |
Biosimilar |
This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines. |
Publication details | |
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Marketing-authorisation holder |
Techdow Pharma Netherlands B.V.
|
Revision |
17
|
Date of issue of marketing authorisation valid throughout the European Union |
15/09/2016
|
Contact address |
Product information
21/12/2020 Inhixa - EMEA/H/C/004264 - IAIN/0074/G
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
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
Antithrombotic agents
Therapeutic indication
Inhixa is indicated for adults for:
- Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery.
- Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL).
- Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism.
- Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA).
- Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
- Blood clot prevention in the extracorporeal circulation during haemodialysis.