Thorinane
enoxaparin sodium
Table of contents
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.
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
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.