During its January 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral of terlipressin medicines. The PRAC also has recommended a change to the product information for Vaxzevria and COVID-19 Vaccine Janssen. The PRAC discussed direct healthcare professional communication (DHPC) containing important safety information for Mavenclad.
PRAC January 2022 – Review of terlipressin medicines started, update of COVID-19 vaccins and new safety information for Mavenclad
Manufacturers, importers and distributors of human and veterinary medicines must check their data in the Organisation Management Service database of the EMA
From 28 January 2022, new regulations will come into force for manufacturers, importers and distributors of medicines for human and veterinary use. The FAMHP is asking them to check from 28 January 2022 onwards whether their organisation's data are correctly registered in the Organisation Management Service of the European Medicines Agency (EMA).
Give your opinion on a genetically modified medicine for the treatment of Duchenne muscular dystrophy
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine SRP-9001 for the treatment of Duchenne muscular dystrophy. The public consultation runs from 17 January 2022 to 16 February 2022.
Give your opinion on a genetically modified medicine for the treatment of various types of advanced cancer
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial testing the genetically modified oncolytic virus VSV-GP (BI 1831169), for the treatment of patients with various types of advanced cancer (solid tumours). The public consultation runs from 11 January 2022 to 10 February 2022.
The availability of RoActemra (tocilizumab), a drug used for certain rheumatological and hematological disorders, can still not be fully guaranteed. Currently, there is a stock for both the intravenous and subcutaneous form of administration, taking into account the previously approved indications, i.e. exclusive use in COVID-19 patients. Based on the information currently available to the FAMHP, Roche will also not be able to confirm deliveries long in advance in the coming months.
Due to a decrease in the availability of subcutaneous immunoglobulins around the world, there is also a critical level of limited availability in Belgium. The FAMHP issues several recommendations for hospital and retail pharmacists, medical doctors (specialists), and patients.
Eco-Med Pharmaceuticals Inc. has found that some batches of their ultrasound gel might be contaminated by a bacterium which can cause an infection among immunocompromised patients. Therefore, the gel has been recalled.
PRAC December 2021 – Assessment of recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax
During the December 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has assessed recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax.
The FAMHP is organising the second information session on the new Clinical Trial Regulation (CTR) for sponsors and applicants of clinical trials on 15 December 2021 from 9 a.m. to 12 noon. The presentation and questions and answers of the first info session are now available.
The applicant or marketing authorisation holder for a generic medicine may decide not to include the patented indications or dosage forms in the marketing authorisation and not to mention them in the summary of product characteristics and package leaflet. Applicants/marketing authorisation holders must follow specific procedures to remove or reinsert the patented indication.