Home hospitalisation

Home hospitalisation offers patients the opportunity to continue treatment started in hospital at home, receiving the medicines and medical care in their familiar surroundings. This can contribute significantly to their comfort and well-being. By combining the benefits of hospital care with the convenience of staying at home, home hospitalisation is ideal for patients who need extended care, but do not necessarily need to be lying in a hospital bed. Furthermore, it can reduce pressure on hospitals and healthcare providers.

Availability of medical devices on the EU market: manufacturers, authorised representatives, importers and distributors, your opinion is important for us

Upon request by the European Commission, a survey intended for economic operators is ongoing to monitor and analyse the availability of medical devices on the EU market in the context of the implementation of European Regulations 2017/745 (MDR) and 2017/746 (IVDR). This survey aims to identify obstacles that could affect availability of devices and/or impair the conformity assessment process, pointing to potential solutions.

Evaluation of European regulations on medical devices: the European Commission launches a public consultation

The European Commission has launched a public consultation to assess Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) on medical devices and in vitro diagnostic medical devices. The aim of this initiative is to gather stakeholders' opinions on the effectiveness of the current regulations and to identify any shortcomings.

Obligation for manufacturers to notify interruptions or discontinuations in the supply of medical devices and in vitro diagnostic medical devices

From 10 January 2025, manufacturers will have to report interruptions or discontinuations in the supply of medical devices and in vitro diagnostic medical devices placed on the European Union market for which it is reasonably foreseeable that such absence from the European market could endanger patient or public health in one or more countries.

Xtandi

Recommendations for paclitaxel-coated balloons and paclitaxel-eluting stents remain unchanged

In 2019, the FAMHP published recommendations for the use of paclitaxel-coated balloons and paclitaxel-eluting stents. The European Commission recently published a scientific advice from an expert panel. The expert panel's advice contains no new elements that change the previous recommendations.

European Medicines Agency launches platform for a better monitoring of medicine shortages

The European Medicines Agency has launched the European Shortages Monitoring Platform. For reporting at European level, marketing authorisation holders can now report shortages for centrally authorised medicines to the European Medicines Agency through this platform. For reporting at national level, PharmaStatus remains the reference in Belgium for reporting medicine shortages.

Flash VIG-news : Marketing stop of Depakine (sodium valproate) 300 mg/5 ml syrup - beware of medication errors

Sanofi Belgium has decided to stop marketing Depakine 300 mg/5 ml syrup as of 28 April 28 2025. However, Depakine's other oral liquid formulation, the 300 mg/ml oral solution, will remain available in Belgium. As this drink is more concentrated than the syrup and dosed with a different device, patients, healthcare professionals and parents need to be informed and prepared to avoid potential medication errors.
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Active substance enzalutamide
Holder Astellas Pharm B.V.a
Status Running
Indication As monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy
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