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.
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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.
Call to professionals responsible for materiovigilance: take part in European Commission survey on electronic instructions for use
The European Commission is considering allowing the use of electronic instructions for use for all devices for professional use. The Commission is therefore launching a survey for healthcare professionals.
Warning: serious adverse reactions when administering the veterinary medicinal product Senvelgo (velagliflozin molecule) to cats suffering from diabetes
The Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA), having analysed recent reports on diabetic ketoacidosis associated with Senvelgo use, now issues recommendations.
PRAC July 2024 – New recommendations for GLP-1 receptor agonists and direct healthcare professional communication for glatiramer acetate containing products
During its July 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency issued new recommendations for GLP-1 receptor agonists and agreed a direct healthcare professional communication for glatiramer acetate containing products.
Improving the availability of in vitro diagnostics: European measures
New measures published in the European Union’s Official Journal come into effect to improve the availability of in vitro diagnostics, for patients and healthcare providers.
PRAC June 2024 – PRAC started review of painkiller metamizole and identified risk of secondary malignancies of T-cell origin with CAR T-cell medicines
During its June 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency started a review of the painkiller metamizole and identified a risk of secondary malignancies of T-cell origin with CAR T- cell medicines.
Kexxtone: suspension of marketing authorisation and recall of all batches
The EMA's Committee for Veterinary Medicinal Products (CVMP) recommends suspending the marketing authorisation for Kexxtone 32.4 g continuous-release intraruminal device for cattle (EU/2/12/145/001-003) and recalling batches from the market.