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Limited availability of RoActemra (Roche): new situation update
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.
Limited availability of subcutaneous immunoglobulins
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.
Recall of ultrasound gel from Eco-Med Pharmaceuticals Inc.
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.
Second information session on the new Clinical Trial Regulation (CTR) on 15 December 2021
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.
Evrenzo®
Active substance roxadustat Holder Astellas Pharma B.V. Status closed Indication treatment of symptomatic anaemia of Chronic Kidney Disease in non-dialysis and dialysis patients, and where use of available treatment (IV iron or injectable ESAs) is not appropriate or is expected not to be appropriate, or patients who have a known contraindication for the currently available treatment or who do not tolerate the currently available treatment, or are expected not to tolerate this product Public documents Approbation Approbation-Amendment_1 Information for the patient Information for the patient-Amendment_1 Informed Consent Informed consent-Amendment_1 Laast update 22/01/2024
Darzalex
Active substance daratumumab Holder Janssen-Cilag NV Status closed Indication in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic amyloid light chain (AL) amyloidosis Public documents Approbation Information for the patient Informed consent Last update 26/10/2023
Procedure for removal or addition of a patented indication for medicines for human use
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.
2019 Archives presentations
You can find the presentations that were given at workshops and symposia at the FAMHP here. “Working together with and for the patient” symposium – 10 december 2019 Patient engagement and Patient Expert Centre – Erik Briers (PEC) Betrokkenheid van de patiënt in nationale aanvragen voor Scientific-Technical Advice betreffende klinische roeven : FAGG Pilootproject – Christophe Lahorte (FAMHP) Toekomstige betrokkenheid van de patiënt in de beoordeling van aanvragen voor klinische proeven – Voorstelling van het toekomstig pilootproject van het FAGG – Pieter Vankeerberghen (FAMHP) Betrokkenheid van de patiënt in de ontwikkeling van de Informed Consent Form (ICF): een korte update