🇪🇺 Enoxaparin in European Union

EMA authorised Enoxaparin on 14 September 2016

Marketing authorisations

Application: EMEA/H/C/003795
Marketing authorisation holder: Pharmathen S.A.
Local brand name: Thorinane
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 i
Pathway: biosimilar
Status: withdrawn

Application: EMEA/H/C/004264
Marketing authorisation holder: Techdow Pharma Netherlands B.V.
Local brand name: Inhixa
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,
Pathway: biosimilar
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is Enoxaparin approved in European Union?

Yes. EMA authorised it on 14 September 2016; EMA authorised it on 15 September 2016.

Who is the marketing authorisation holder for Enoxaparin in European Union?

Pharmathen S.A. holds the EU marketing authorisation.