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Public Health

Health Products Regulatory Authority (HPRA) safety notices

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PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids

The Health Products Regulatory Authority writes to inform you on the outcome of a review by the European Medicines Agency's safety committee (PRAC) of 5-mg ulipristal acetate (Esmya and generic medicines) used for the treatment of symptoms of uterine fibroids and the risk of serious liver injury, including the need for transplantation. » read more

COVID-19 testing in Ireland by commercial entities outside the National Testing Strategy

Attached, please find a copy of the HPRA Information Notice IN2020(04) in relation to COVID-19 testing in Ireland by commercial entities outside the National Testing Strategy, for your information. » read more

Suspension of ulipristal acetate for treatment of uterine fibroids during ongoing EMA review of liver injury risk

The Health Products Regulatory Authority writes to inform you that the European Medicines Agency (EMA) has recommended temporary suspension the marketing authorisation of 5-mg ulipristal acetate (Esmya and generic medicines) indicated for treatment of uterine fibroids throughout the European Union while the Pharmacovigilance Risk Assessment Committee (PRAC), EMA's safety committee, reviews the risk of serious liver injury. » read more

Medicine Recall - Emerade

All in-date batches of Emerade solution for injection pre-filled pens were recalled in Ireland on September 30 2019, following a number of reports on other markets of failure to activate. » read more

HSE HPSC updated national guidance on Novel coronavirus 2019-nCoV

The Health Protection Surveillance Centre (HSE HPSC) has requested that we circulate the updated information as attached in relation to national guidance for risk assessment and infection prevention and control Coronavirus. » read more

Novel Coronavirus infection - Update for GPs on the emerging picture on the Novel Coronavirus infection

Update for GPs on the emerging picture on the Novel Coronavirus infection - 10 February 2020 » read more

Picato (ingenol mebutate)

Suspension of the marketing authorisation due to risk of skin malignancy » read more

WHO IHR emergency committee decision on novel coronavirus outbreak in China

Statement on the meeting of the International Health Regulations (2005) Emergency Committee regarding the outbreak of novel coronavirus 2019 (n-CoV) on 23 January 2020 » read more

WHO Euro-Update on Novel Corona virus (2019-nCoV) in Wuhan China - Guidance and update

Following the news of an outbreak of a novel corona virus (2019-nCoV) in Wuhan, China, the WHO Regional Office would like to share with you some updated sources of information. There has been significant interest in ensuring European Region Member States are prepared should the Region be affected. » read more

Updated ECDC Rapid Risk Assessment: Cluster of pneumonia cases caused by a novel coronavirus, Wuhan, China, 2020

Since 31 December 2019 and as of 17 January 2020, 205 laboratory confirmed cases of novel coronavirus 2019-nCoV infection, including three deaths (case fatality ratio: 1.5%), have been reported in Wuhan City, China. In addition, three cases of 2019-nCoV have been reported in Beijing (2) and Guangdong (1) in China, all with a travel history to Wuhan. A further four imported cases ex-Wuhan have been reported in Thailand (2), Japan (1) and South Korea (1). » read more

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