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Fighting antimicrobial resistance: a new antimicrobial medicinal product marketed in Belgium
In the fight against antimicrobial resistance, it is important to improve the diversity of therapeutic treatments to enable medical doctors to make the most appropriate choice. Maribavir, a new viral active substance, has recently been launched on the Belgian market.
Marketing authorisation holders: mandatory update of contact details in product information for reporting adverse reactions to the FAMHP
The current postbox address of the FAMHP is no longer applicable. The contact details for reporting adverse reactions to the FAMHP should be changed by marketing authorisation holders in the product information of medicinal products for human use as soon as possible.
PRAC March 2024 – PRAC finds no link between postmenopausal bleeding and mRNA COVID-19 vaccines
During the March 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that there is no link between postmenopausal bleeding and mRNA COVID-19 vaccines.
Give your opinion on a genetically modified medicine for the treatment of hemophilia B
The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine PF-06838435 for the treatment of hemophilia B. The public consultation runs from 28 February 2024 to 28 March 2024.
Self-checking guides
Self-checking guide for distributors: Guidance for distributors of medical device s (version 2.1 – dd 26 May 2021) Self-checking guide for STHA (service and technical home assistance) Guidance for the implementation of a self-checking system related to the installation, maintenance, and/or removal of medical devices used in the diagnosis and treatment of sleep apnea syndrome ( Fr / Nl ) (version 1.0 – dd 15 January 2024)
3Rs conference - 31 January 2024 - presentations
Presentations 1. Opening and welcome Advancing the 3Rs for Regulatory Testing of Medicines - Sonja Beken (FAMHP) The Pharmaceutical Strategy’s role in strengthening the 3Rs principle - Sara Rafael Almeida (DG SANTE (EC)) 2. Contribution of the FAMHP to the 3Rs Advancing the 3Rs at the EMA: From the Joint Expert Group on 3Rs to the new 3Rs Working Party - Sonja Beken (FAMHP) Non-clinical testing of human medicinal products and 3Rs - Karen Van Malderen (FAMHP) The risk-based approach for ATMPs – a new paradigm with 3Rs opportunities - Claire Beuneu (FAMHP) Implementing the 3Rs in Quality Control and
PRAC February 2024: reminder of serious adverse reactions when Paxlovid is taken in combination with certain immunosuppressants
During its February 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency reminded healthcare professionals of the risk of serious and potentially fatal adverse reactions with Paxlovid when used in combination with certain immunosuppressants.
Give your opinion on a genetically modified medicine for the treatment of limb girdle 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-9003 for the treatment of limb girdle muscular dystrophy. The public consultation runs from 14 February 2024 to 14 March 2024.
Orladeyo®
Active substance Berotralstat dihydrochloride Holder Biocryst Ireland Limited Status Running Indication Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. Public documents Approbation Information for the patient Informed consent Last update 13/02/2024