Thorinane

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enoxaparin sodium

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

Overview

This is a summary of the European public assessment report (EPAR) for Thorinane. 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 Thorinane.

For practical information about using Thorinane, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 14/09/2017

Authorisation details

Product details
Name
Thorinane
Agency product number
EMEA/H/C/003795
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
Marketing-authorisation holder
Pharmathen S.A.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
14/09/2016
Contact address
Techdow Pharma Netherlands B. V.
Strawinskylaan 1143, Toren C-11
1077XX Amsterdam
Netherlands

Product information

05/09/2017 Thorinane - EMEA/H/C/003795 - T/0003

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

Thorinane 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.

Prevention and treatment of various disorders related to blood clots in adults.

Assessment history

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