Fondaparinux sodium Evumed (fondaparinux sodium)

Where it stands

Fondaparinux sodium Evumed (fondaparinux sodium), from Evumed Limited, received a positive CHMP opinion on 12 November 2026. The records show its status as "Opinion". No approval date is recorded, so the European Commission (EC) has not yet granted marketing authorisation according to the data provided.

The indication in the records covers adults: prevention of venous thromboembolic events (VTE), treatment of deep vein thrombosis (DVT), treatment of pulmonary embolism, and treatment of unstable angina and myocardial infarction. The therapeutic areas listed are venous thrombosis, pulmonary embolism, myocardial infarction and unstable angina.

The next step is the EC decision. The records give an expected date of 18 January 2027, calculated as the CHMP opinion date plus 67 days, the standard Commission decision period. This is an estimate, not an official date.

Regulatory pathway and designations

The product carries a Generic designation. In general, a generic medicine is authorised on the basis of its similarity to an already authorised medicine, rather than a full independent clinical development programme. The records do not name the reference medicine or the specific legal basis, so neither is assumed here.

A CHMP opinion is the scientific recommendation of the European Medicines Agency's committee. It is not itself a marketing authorisation. Authorisation takes effect only when the EC adopts its decision, normally following the opinion, which is why the approval date field is still empty.

The records list the same active substance under two other names in the EU: Arixtra (Authorised) and Quixidar (Withdrawn). This shows an authorised product with the same substance is on the EU market. The records do not say which of these, if either, is the reference product, or why Quixidar was withdrawn.

Safety and pharmacovigilance

The records contain no safety data, risk management plan details, or pharmacovigilance commitments for this product, so no assessment can be made from them.

What to watch

The main event is the EC decision, estimated for around 18 January 2027. Because that date is a calculated estimate, the actual decision could fall earlier or later. Confirmation of the authorisation and its date should come from official EC and EMA sources.

Once a decision is published, the authorised product information should show whether the final indication wording matches the one in the records. Launch timing, pricing and market entry are not covered by the records and cannot be inferred from them.

Arixtra remains authorised in the EU, and Quixidar is recorded as withdrawn. Anyone tracking the competitive landscape for this substance may want to watch how the authorisation landscape for these products develops after the decision.