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PRAC October 2024 – The EMA started safety review of medicines containing finasteride and dutasteride

During its October 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency started safety review of medicines containing finasteride and dutasteride, to assess data related to suicidal thoughts and behaviours. Furthermore the PRAC formulated new safety information intended to healthcare professionals (DHPC) regarding a risk of medication errors due to change of dosing syringe for Keppra oral solution 150ml 100mg (levetiracetam)/1ml (with dosing syringe of 3 ml).

Import of medicinal products by wholesalers in case of special needs: publication of notification forms

On 1 November 2024, the new Article 105/1 came into force. Wholesalers will be allowed to distribute medicinal products that are not authorised in Belgium in our country if they meet a special need in Belgium due to a critical unavailability. The notification forms are now available.

Give your opinion on a genetically modified vaccine for the treatment of hepatitis B

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified vaccine LAV-YF17D/HBc (AVX70371) for the treatment of hepatitis B. The public consultation runs from 30 October 2024 to 29 November 2024.

Publication of Article 105/1: import of medicinal products by wholesalers in case of special needs

Wholesalers will be allowed to distribute medicinal products that are not authorised in Belgium in our country if they meet a special need in Belgium due to a critical unavailability, as determined by the Federal Agency for Medicines and Health Products (FAMHP).

Flash VIG-news: European review of finasteride and dutasteride-based medicinal products

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is going to evaluate data relating to suicidal ideation and behaviour.

Vaccine against epizootic haemorrhagic disease virus: authorisation for use in Belgium

The FAMHP authorises the use of the immunological veterinary medicinal product Hepizovac (suspension for injection from the company CZ Vaccines S.A.U.) intended for cattle.

PRAC September 2024 – Recommendation for metamizole and to minimise the risk associated with medroxyprogesterone acetate

The PRAC recommends measures to minimise serious outcomes of known side effect with the painkiller metamizole and formulated new recommendations to minimise the risk of meningioma with medicines containing medroxyprogesterone acetate. During its September 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended measures to minimise serious outcomes of known side effect with painkiller metamizole and formulated new recommendations to minimise the risk of meningioma with medicines containing medroxyprogesterone acetate.

Limited availability of Zypadhera powder and solvent for suspension with prolonged release used for injections: recommendations update

Because of a delay in the planned deliveries of the Zypadhera medicinal product (intramuscular (IM) olanzapine with prolonged disease) by the Cheplapharm Registration company, supplies in Belgium are limited. The availability of these medicinal products is also limited in other European countries. Therefore, the experts of the Unavailability Task Force update the previous recommendations.

Limited availability of medicinal product based on peginterferon alfa-2a, solution for injection: recommendations for physicians (-specialists) and (hospital) pharmacists.

The medicinal product Pegasys® 180µg, solution for injection, will have limited availability in Belgium until June 2025. Experts of the task force Unavailability recommend the following.

Flash VIG-news: Benzodiazepine withdrawal programme extended until 31 December 2024

Since 1 February 2023, a withdrawal programme can be provided for outpatients taking benzodiazepines or Z-drugs. This programme is based on the magistral preparation of capsules following a doctor's prescription. The project, which was initially due to run for one year, has been extended until 31 December 2024.

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