Flupentixol/melitracen-containing medicinal products - referral

Current status

Procedure started

Overview

PRAC starts review of depression and anxiety medicine Deanxit (flupentixol/melitracen).

Review triggered by reports of side effects affecting movement, memory and thinking.

Background

EMA’s safety committee (PRAC) has started a review of Deanxit, a fixed-dose combination medicine for treating depression and anxiety, following reports of serious neurological and psychiatric side effects in patients taking the medicine.

The reports concern cases involving movement disorders, such as tremors, stiffness, restlessness and involuntary movements, and memory and thinking problems. In some cases, symptoms persisted after treatment was stopped. 

Although neurological and psychiatric side effects are already listed in the product information, the Belgian medicines agency triggered the review over concerns about the severity and duration of the side effects, as well as prolonged disability and the possibility that some effects may be irreversible. The Belgian agency also questioned the benefits of combining the two active substances in Deanxit.

Deanxit contains the active substances flupentixol and melitracen in a fixed-dose combination. Its uses vary in EU countries but include the treatment of depression, anxiety, asthenia (weakness) and psychological conditions with physical symptoms.

The review by PRAC will evaluate all available data on the benefits and risks of Deanxit and consider whether marketing authorisations of Deanxit should be maintained, varied, suspended or revoked.

More about the medicine

Deanxit is available as tablets containing 0.5 mg of flupentixol and 10 mg of melitracen. 

Flupentixol works by blocking receptors for a chemical messenger called dopamine, which is involved in regulating mood and behaviour. It is also available on its own and is used mainly to treat schizophrenia and other conditions involving psychoses. Medicines containing only flupentixol are not covered by this review.

Melitracen stops the chemical messengers serotonin and noradrenaline from going back into nerve cells. Having these chemical messengers between the nerve cells helps relieve symptoms of depression. Melitracen was previously available on its own for treating depression, but the medicine containing it as a single ingredient is no longer available in the EU.

In EU countries, Deanxit was first authorised in Austria in 1971. It is currently authorised in Austria, Belgium, Bulgaria, Cyprus, Luxembourg, Malta and Spain.

More about the procedure

The review of Deanxit was initiated on 16 October 2026 at the request of the Belgian medicines agency, under Article 31 of Directive 2001/83/EC.

The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations. As Deanxit is authorised nationally, the PRAC recommendations will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a position. The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.

Flupentixol/melitracen-containing medicinal products Article-31 referral - PRAC starts review of depression and anxiety medicine Deanxit (flupentixol/melitracen)

Reference Number: EMA/244566/2026

Key facts

About this medicine

• Approved name:
  Flupentixol/melitracen-containing medicinal products
• International non-proprietary name (INN) or common name:
  • flupentixol
  • melitracen
• Associated names:
  Deanxit
• Class:
  tricyclic antidepressants/antipsychotics

About this procedure

• Current status:
  Procedure started
• Reference number:
  EMA/REF/0000382942
• Type:
  Article 31 referrals

  This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

• Authorisation model:
  Nationally authorised product(s)
• Decision making model:
  PRAC-CMDh

Key dates and outcomes

• Procedure start date:
  29/10/2026

All documents

Procedure started

Flupentixol/melitracen-containing medicinal products Article-31 referral - Annex I

Reference Number: EMADOC-1700519818-3537064

Flupentixol/melitracen-containing medicinal products Article-31 referral - Timetable for the procedure

Reference Number: EMADOC-1700519818-3522264

Flupentixol/melitracen-containing medicinal products Article-31 referral - PRAC list of questions

Reference Number: EMADOC-1700519818-3522249

Flupentixol/melitracen-containing medicinal products Article-31 referral - Notification

Flupentixol/melitracen-containing medicinal products Article-31 referral - PRAC starts review of depression and anxiety medicine Deanxit (flupentixol/melitracen)

Reference Number: EMA/244566/2026

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.