Inhixa (enoxaparin sodium)
- Region
- 🇪🇺 EU
- Active substance
- enoxaparin sodium
- Company
- Techdow Pharma Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Venous Thromboembolism
- CHMP opinion
- Thu 21 Jul 2016
- EU approval
- Thu 15 Sep 2016
- Designations
- Biosimilar
- Application
- EMEA/H/C/004264
- ATC
- B01AB05
- Official record
- www.ema.europa.eu
Indication
Inhixa 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Thorinane Lapsed · Pharmathen S.A.
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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.