Inhixa

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enoxaparin sodium

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

Overview

Inhixa is an anticoagulant medicine (a medicine that prevents blood clots) used in adults for:

• preventing venous thromboembolism (blood clots that form inside the veins, obstructing blood flow), especially in patients who are having surgery or who are at greater risk of clots because they are bedridden due to illness;

• treating deep vein thrombosis (DVT, where the clot develops in a deep vein, usually in the leg) and pulmonary embolism (PE, a clot in a blood vessels supplying the lungs);

• treating DVT and PE in patients with active cancers, and preventing these clotting problems from occurring again;

• treating unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart);

• treating certain types of myocardial infarction (heart attack);

• preventing clots forming when blood is circulated through a haemodialysis machine to remove toxic substances.

In the treatment of unstable angina and heart attack Inhixa is given with aspirin (acetylsalicylic acid).

Inhixa contains the active substance enoxaparin sodium and is a ‘biosimilar medicine’. This means that Inhixa is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Inhixa is Clexane. For more information on biosimilar medicines, see here.

This EPAR was last updated on 01/07/2022

Authorisation details

Product details
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
BiosimilarBiosimilar

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
Marketing-authorisation holder
Techdow Pharma Netherlands B.V. 
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
15/09/2016
Contact address

Strawinskylaan 1143, Toren C-11 
1077XX Amsterdam 
Netherlands

Product information

06/01/2022 Inhixa - EMEA/H/C/004264 - PSUSA/00010833/202104

Product information documents contain:

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

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.

Assessment history

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