Thorinane

Lapsed

This medicine's authorisation has lapsed

enoxaparin sodium

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 theOn 15 September 2019, the marketing authorisation of Thorinane (enoxaparin sodium) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, Techdow Pharma Netherlands B.V., had not marketed Thorinane in the EU since its initial marketing authorisation. 

In accordance with provisions of the sunset clause, the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation. Techdow Pharma Netherlands B.V. confirmed that the product had not been marketed due to business reasons. 

Thorinane was granted marketing authorisation in the EU on 15 September 2016 for prophylaxis of thromboembolic disorders of venous origin. The marketing authorisation was initially valid for a 5-year period. Thorinane was a duplicate application to Inhixa, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Inhixa. 

The European Public Assessment Report (EPAR) for Thorinane is updated to indicate that the marketing authorisation is no longer valid. authorisation.

Thorinane : EPAR - Summary for the public

Reference Number: EMA/511753/2016

Product information

Thorinane : EPAR - Product Information

Thorinane : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Thorinane
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/003795
• 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.

• Marketing authorisation holder:
  Pharmathen S.A.

  Techdow Pharma Netherlands B. V.; Strawinskylaan 1143, Toren C-11; 1077XX Amsterdam; Netherlands

• Opinion adopted:
  20/07/2016
• Marketing authorisation issued:
  14/09/2016
• Lapse of marketing authorisation:
  15/09/2019
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Thorinane : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Thorinane : EPAR - Public assessment report

AdoptedReference Number: EMA/536972/2016

CHMP summary of positive opinion for Thorinane

AdoptedReference Number: EMA/CHMP/482415/2016