Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26 - 29 October 2026

30 Říjen 2026

PRAC starts review of depression and anxiety medicine Deanxit and a safety signal related to human normal immunoglobulin medicines

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

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. 

More information is available in EMA’s start of referral communication.

PRAC reviews increased reporting of allergic reactions with specific batches of human normal immunoglobulin medicines

PRAC has started a review of a safety signal concerning increased reporting of hypersensitivity (allergic) reactions associated with specific batches of human normal immunoglobulin medicines.

Human normal immunoglobulins are used to help prevent infections in people who do not have enough antibodies, including those with certain immune disorders or blood cancers. They are also used to treat some conditions in which the immune system attacks the body’s own tissues.

Hypersensitivity reactions are a known side effect of these medicines. Their product information includes warnings that serious hypersensitivity reactions can occur, even in patients who have previously tolerated treatment. However, reports indicate that hypersensitivity reactions may be occurring more frequently than expected with specific batches of some human normal immunoglobulin medicines.

The reported cases include hypersensitivity reactions of varying severity, from rash and itching to serious and potentially life-threatening hypersensitivity reactions. These included anaphylaxis (a sudden, severe allergic reaction) and angioedema (rapid swelling under the skin that can affect areas such as the face and throat). Clusters of these cases have led to recalls of specific batches of some of these medicines in recent months, including Flebogamma DIF, Yimmugo and Gamunex, in certain EU Member States. These batches have already been withdrawn from the market as a precautionary measure following increased reporting of hypersensitivity reactions.

Despite investigations to date, the cause of these clusters of hypersensitivity reactions has not yet been established. It is also not yet clear whether other human normal immunoglobulin medicines could be affected. The review undertaken by PRAC will therefore cover all human normal immunoglobulin medicines, regardless of how they are given, including those given into a vein (intravenously), under the skin (subcutaneously) or into a muscle (intramuscularly).

PRAC will request all relevant data from the companies marketing these medicines and assess it alongside the available evidence to investigate possible causes and evaluate whether further measures are needed to reduce the risk.

Healthcare professionals are reminded to follow the existing warnings and precautions in the product information, including recommendations to monitor patients during treatment. Patients should seek medical attention without delay if they experience signs of a hypersensitivity reaction, such as rash, dizziness, palpitations, wheezing or difficulty breathing, even if they have not experienced such reactions during previous treatment. EMA will communicate further on the outcome of PRAC’s review.

Information on other ongoing safety referrals is provided in the ‘Ongoing referrals’ section below. 

Information on all topics discussed by the PRAC is available in the agenda.

Agenda

Agenda of the PRAC meeting 26 - 29 October 2026

Draft Reference Number: EMA/PRAC/227255/2026

PRAC statistics: November 2026

Monthly figures for PRAC outcomes based on the draft agenda.

PRAC statistics: Text version

November 2026 statistics:

• 4 safety signals: 1 started, 3 ongoing or concluded
• 67 periodic safety update reports (PSURs) single assessments: 45 recommendations for centrally authorised medicines only, 20 recommendations for nationally authorised medicines only, 2 recommendations for PSURs including both centrally and nationally authorised medicines
• 42 risk management plans (RMPs) for centrally authorised medicines: 10 RMPs reviewed for new medicines, 32 RMPs reviewed for authorised medicines
• 18 post-authorisation safety studies (PASSs): 13 protocols for imposed and non-imposed studies reviewed, 5 results from imposed and non-imposed studies reviewed
• 1 referral discussed: 1 started, 0 ongoing, 0 concluded

Ongoing referrals

Procedure: Flupentixol/melitracen-containing medicinal products - referral

Procedure: Parenteral iron-containing medicinal products - referral

Glossary

• Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine and an adverse event that warrants further investigation. Safety signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under 'Signal management'.
• Periodic safety update reports, abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under 'Periodic safety update reports: questions and answers'.
• Risk management plans, abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under 'Risk-management plans'.
• Post-authorisation safety studies, abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under 'Post-authorisation safety studies'.
• Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under referral procedures.