Thorinane

enoxaparin sodium

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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.

What is Thorinane and what is it used for?

Thorinane is an anticoagulant medicine (a medicine to prevent blood clots). It is used in adults for the following:

  • to prevent 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;
  • to treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg);
  • to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart);
  • to treat certain types of myocardial infarction (heart attack);
  • to prevent clots forming when blood is circulated through a haemodialysis machine to remove toxic substances.

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

The active substance in Thorinane is enoxaparin sodium.

Thorinane is a ‘biosimilar medicine’. This means that Thorinane is highly similar to a biological medicine (also known as the ‘reference medicine’) that is already authorised in the European Union (EU). The reference medicine for Thorinane is Clexane.

How is Thorinane used?

Thorinane is available as a solution for injection in pre-filled syringes. It is usually given as an injection under the skin although in the treatment of a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI) it is first given as an injection into a vein, and to prevent clots in haemodialysis machines it is injected directly into the tube carrying the blood. The dose and how long the medicine is given for, as well as whether it is given with other medicines, depend on the condition to be prevented or treated. Doses must be adjusted in patients with severely reduced kidney function.

The medicine can only be obtained with a prescription. For further information, see the package leaflet.

How does Thorinane work?

When blood clots develop inside blood vessels they may restrict the blood flow to the organs, including the heart. The active substance in Thorinane, enoxaparin, is one of a group of anticoagulant medicines called ‘low-molecular weight heparins’. Enoxaparin increases the effect of antithrombin III, a natural substance that controls the blood’s clotting factors and helps prevent blood from clotting inside the body. This helps to stop the formation of new blood clots and control existing ones.

What benefits of Thorinane have been shown in studies?

Extensive laboratory studies comparing Thorinane with Clexane have shown that Thorinane is highly similar to Clexane in terms of structure, purity and biological activity.

In addition, a study in 20 healthy subjects has shown that the same doses of the two products given by injection under the skin produced similar effects on blood clotting factors, using various measures that reflect the way the medicine works in the body.

The company also provided information from published studies showing the benefits of enoxaparin in preventing and treating blood clots.

What are the risks associated with Thorinane?

The most common side effect with Thorinane (which may affect more than 1 in 10 people) is haemorrhage (bleeding); serious bleeding occurred in around 4 people in 100 given Thorinane to prevent blood clots during surgery. In addition, increased levels of liver enzymes in the blood (a sign of possible liver problems) are very common (may affect more than 1 in 10 people).

For the full list of all side effects reported with Thorinane, see the package leaflet.

Thorinane must not be used in patients with existing major bleeding, severe disorders of blood clotting, or with conditions that increase the risk of, or from, bleeding, such as stomach ulcers or stroke. For the full list of restrictions, see the package leaflet.

Why is Thorinane approved?

Studies have shown that Thorinane has a highly similar structure and biological activity to Clexane and has the same effect on blood clotting factors. The safety profiles of the two medicines were also considered similar, based on laboratory testing.

Therefore, the Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically meaningful differences between Thorinane and Clexane in terms of effectiveness and safety and took the view that, as for Clexane, the benefit outweighs the identified risk. The Committee recommended that Thorinane be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Thorinane?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thorinane have been included in the summary of product characteristics and the package leaflet.

Other information about Thorinane

The European Commission granted a marketing authorisation valid throughout the European Union for Thorinane on 15 September 2016.

For more information about treatment with Thorinane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Thorinane : EPAR - Summary for the public BG = bălgarski 2016-10-26  
Thorinane : EPAR - Summary for the public ES = español 2016-10-26  
Thorinane : EPAR - Summary for the public CS = čeština 2016-10-26  
Thorinane : EPAR - Summary for the public DA = dansk 2016-10-26  
Thorinane : EPAR - Summary for the public DE = Deutsch 2016-10-26  
Thorinane : EPAR - Summary for the public ET = eesti keel 2016-10-26  
Thorinane : EPAR - Summary for the public EL = elliniká 2016-10-26  
Thorinane : EPAR - Summary for the public EN = English 2016-10-26  
Thorinane : EPAR - Summary for the public FR = français 2016-10-26  
Thorinane : EPAR - Summary for the public IT = italiano 2016-10-26  
Thorinane : EPAR - Summary for the public LV = latviešu valoda 2016-10-26  
Thorinane : EPAR - Summary for the public LT = lietuvių kalba 2016-10-26  
Thorinane : EPAR - Summary for the public HU = magyar 2016-10-26  
Thorinane : EPAR - Summary for the public MT = Malti 2016-10-26  
Thorinane : EPAR - Summary for the public NL = Nederlands 2016-10-26  
Thorinane : EPAR - Summary for the public PL = polski 2016-10-26  
Thorinane : EPAR - Summary for the public PT = português 2016-10-26  
Thorinane : EPAR - Summary for the public RO = română 2016-10-26  
Thorinane : EPAR - Summary for the public SK = slovenčina 2016-10-26  
Thorinane : EPAR - Summary for the public SL = slovenščina 2016-10-26  
Thorinane : EPAR - Summary for the public FI = suomi 2016-10-26  
Thorinane : EPAR - Summary for the public SV = svenska 2016-10-26  
Thorinane : EPAR - Summary for the public HR = Hrvatski 2016-10-26  

This EPAR was last updated on 26/10/2016 .

Authorisation details

Product details

Product details for Thorinane
NameThorinane
Agency product numberEMEA/H/C/003795
Active substance

enoxaparin sodium

International non-proprietary name (INN) or common name

enoxaparin sodium

Therapeutic area Venous Thromboembolism
Anatomical therapeutic chemical (ATC) code B01AB05
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Thorinane
Marketing-authorisation holder

Pharmathen S.A.

Revision0
Date of issue of marketing authorisation valid throughout the European Union15/09/2016

Contact address:

Pharmathen S.A.
6 Dervenakion Street 
Athens 
5351 Pallini 
Greece

Product information

Product information

15/09/2016  Thorinane -EMEA/H/C/003795 --

Name Language First published Last updated
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  
Thorinane : EPAR - Product Information HR = Hrvatski 2016-10-26  

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.


Name Language First published Last updated
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  
Thorinane : EPAR - All Authorised presentations HR = Hrvatski 2016-10-26  

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

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Thorinane : EPAR - Public assessment report HR = Hrvatski 2016-10-26  
CHMP summary of positive opinion for Thorinane HR = Hrvatski 2016-07-22  

Authorised

This medicine is approved for use in the European Union

More information on Thorinane