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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.

VIG newsflash: take care in sunlight when using certain medicines

Some medicines may cause (severe) skin reactions if the skin is exposed to UV light (from the sun or from an artificial source). The FAMHP is drawing attention to the different types of light sensitivity, which common medicines present an increased risk, the reports it has received, and a number of precautionary measures.

PRAC April 2024 – PRAC finds no link between suicidal thoughts and thoughts of self-harm and GLP-1 receptor agonists and new safety information for HCPs on new Rybelsus tablets

During its April 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there is no available evidence supporting a link between GLP-1 receptor agonists and suicidal thoughts and thoughts of self-harm and advice to CHMP on new Rybelsus tablets.

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.

PRAC January 2024: precautions for children whose father used a valproate-based medicine

During its January 2024 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommends precautionary measures regarding the potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines.

PRAC November 2023 – Conclusion regarding available evidence not supporting link between the glucagon-like peptide-1 (GLP-1) receptor agonists and thyroid cancer

During its November 2023 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that the available evidence does not support a causal association between the glucagon-like peptide-1 (GLP-1) receptor agonists - exenatide, liraglutide, dulaglutide, semaglutide, and lixisenatide - and thyroid cancer.

PRAC January 2023 - recommendations for Janus kinase (JAK) inhibitors and information about Zolgensma

Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors and New safety information for healthcare professionals for Zolgensma

Flash VIG-news: Pregabalin (Lyrica and generics): risks of misuse, abuse, and dependence

For several years, health authorities in European countries have noted a worrying increase in pregabalin abuse. Here are some reminders of the risks of misuse, abuse, and addiction with pregabalin.

MedSafetyWeek 2022: annual campaign to promote adverse reactions reporting

The global MedSafetyWeek runs from 7 to 13 November 2022. During this annual social media campaign, the FAMHP is also encouraging everyone to report suspected adverse reactions to medicinal products.

Flash VIG-news : Dispensation of pholcodine-containing medicinal products suspended due to the risk of allergic cross-reactivity with neuromuscular blocking agents

Due to concerns about the risk of anaphylactic reactions, the dispensation of pholcodine-containing medicinal products is suspended from 1 October 2022.

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