Switzerland – Déclarations d’effets indésirables présumés de vaccins contre le COVID-19 évaluées en Suisse
Depuis le rapport standard final sur les déclarations d’effets indésirables présumés des vaccins COVID-19 évaluées en Suisse de fin février 2023, 720 déclarations ont été évaluées....
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2024
PRAC elects new chair
The July 2024 meeting of EMA’s safety committee (PRAC) was the last plenary meeting chaired by Sabine Straus, who retires as Chair after...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its June 2024 meeting.
The committee recommended granting a marketing authorisation for Balversa (erdafitinib), for the treatment of adult...
Europe – EMA proposes revamping COVID-19 vaccine guidance for the post-pandemic era
The European Medicines Agency (EMA) is proposing to update its COVID-19 guidances to reflect new developments in the non-clinical and clinical development areas. It...
Europe – Commission authorises Chikungunya vaccine and funds new mosquito eradication programme
The Commission has today authorised the first-ever vaccine against Chikungunya virus - a disease transmitted by infected mosquitoes.
While Chikungunya is not endemic in the EU, the...
Europe – Core summary of product characteristics for human plasma-derived and recombinant coagulation factor...
This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor IX products, which are...
Europe – Clinical investigation of recombinant and human plasma-derived factor IX products – Scientific...
This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor IX products is made for use...
Europe – First nasal adrenaline spray for emergency treatment against allergic reactions
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Eurneffy (epinephrine), the first medicine to be taken through the...
Europe – Positive CHMP opinion on first-in-class medicine to treat pulmonary arterial hypertension
EMA has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH), in combination with...
Europe – EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
EMA’s human medicines committee (CHMP) has recommended not renewing the conditional marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy. Translarna...
