Thorinane (enoxaparin sodium)
- Region
- 🇪🇺 EU
- Active substance
- enoxaparin sodium
- Company
- Pharmathen S.A.
- Status
- Lapsed
- Therapeutic area
- Venous Thromboembolism
- CHMP opinion
- Wed 20 Jul 2016
- EU approval
- Wed 14 Sep 2016
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/003795
- ATC
- B01AB05
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Inhixa Authorised · Techdow Pharma Netherlands B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.