News FAMHP

Since 2024, Zypadhera (powder and solvent for prolonged release suspension for injection) has been subject to limited availability. Availability has since improved. Therefore, distribution restrictions have been be gradually and carefully relaxed since 1 January 2026. The FAMHP Task Force Unavailability issues recommendations with a view to further easing.

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine ATSN-201 for the treatment of Retinoschisis. The public consultation will take place from 8 June to 8 July 2026.

You risk developping (harsh) skin reactions when exposed to ultraviolet radiation (whether it’s from sun rays or from an artificial light source) while using certain medicinal products. The FAMHP provides an update on this issue.

From 28 May 2026, the use of the first modules of EUDAMED, the European database on medical devices, has become mandatory.

Manufacturers and other stakeholders are invited to take part in the training on the European Medical Device Nomenclature organised by the SMEMDN consortium, which will take place on 4 June 2026.

The FAMHP has updated the guidelines related to paracetamol for marketing authorisation applicants and holders. Stakeholders are invited to comment on these changes.

The FAMHP would like to remind caregivers of the main recommendations to prevent dosing errors when administering paracetamol to children, particularly with oral solutions.

During its April 2026 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency agreed on communication to healthcare professionals about cases of severe liver injury with the epilepsy medicine Ontozry.

Many liquid medicines, food supplements, medical devices … come in liquid form, bottled in vials of different sizes. Such vials can easily be confused, which can be dangerous. Always check the product you intend to use.

As part of the gradual implementation and mandatory use of EUDAMED, the European Commission is organising a series of webinars in April and May 2026 to support economic operators in using the system.