Thorinane

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enoxaparin sodium

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Thorinane has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

This EPAR was last updated on 24/10/2019

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 monitoringAdditional 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.

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
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

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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

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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